Trial Outcomes & Findings for A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome (NCT NCT03721107)

NCT ID: NCT03721107

Last Updated: 2022-01-11

Results Overview

Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity \[API\] and stool frequency \[SF\] or consistency \[SC\]) for greater than or equal to (\>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for stool frequency was defined as increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with baseline for Cohort C and for stool consistency was defined as decrease at least 50% in the proportion of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline for Cohort D. Participants with \<4 weeks available were considered non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 366 participants
• Primary outcome timeframe: Baseline up to Week 8
• Results posted on: 2022-01-11

Participant Flow

A total of 366 participants were randomized across 30 study centers in Ireland, United Kingdom, and United States between 11 October 2018 (first participant enrolled) and 13 May 2020 (last participant completed study).

Participants who met the eligibility criteria were randomized to receive Blautix or Placebo in either Cohort C or Cohort D depending on classification of IBS subtype by the study doctor.

Participant milestones

Measure	Cohort C: Blautix Participants diagnosed with Irritable Bowel Syndrome Subtype-C (IBS-C) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 most probable number (MPN).	Cohort C: Placebo Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix Participants diagnosed with Irritable Bowel Syndrome Subtype-D (IBS-D) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Overall Study STARTED	80	84	98	104
Overall Study Treated	80	84	97	104
Overall Study COMPLETED	75	81	83	92
Overall Study NOT COMPLETED	5	3	15	12

Reasons for withdrawal

Measure	Cohort C: Blautix Participants diagnosed with Irritable Bowel Syndrome Subtype-C (IBS-C) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 most probable number (MPN).	Cohort C: Placebo Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix Participants diagnosed with Irritable Bowel Syndrome Subtype-D (IBS-D) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Overall Study Adverse Event	1	1	6	5
Overall Study Lost to Follow-up	2	0	3	0
Overall Study Inclusion/Exclusion Criteria not Met	0	0	0	1
Overall Study Physician Decision	0	1	0	0
Overall Study Pregnancy	0	0	1	0
Overall Study Withdrawal by Subject	1	1	5	5
Overall Study Other	1	0	0	1

Baseline Characteristics

A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome

Baseline characteristics by cohort

Measure	Cohort C: Blautix n=80 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=84 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=97 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=104 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Total n=365 Participants Total of all reporting groups
Sex: Female, Male Female	67 Participants n=5 Participants	69 Participants n=7 Participants	60 Participants n=5 Participants	73 Participants n=4 Participants	269 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants	31 Participants n=4 Participants	96 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	61 Participants n=21 Participants
Age, Continuous	44.6 years STANDARD_DEVIATION 13.04 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.41 • n=7 Participants	43.1 years STANDARD_DEVIATION 13.65 • n=5 Participants	44.9 years STANDARD_DEVIATION 14.40 • n=4 Participants	44.4 years STANDARD_DEVIATION 13.65 • n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	63 Participants n=7 Participants	87 Participants n=5 Participants	94 Participants n=4 Participants	304 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	33 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	81 Participants n=21 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	50 Participants n=7 Participants	86 Participants n=5 Participants	90 Participants n=4 Participants	274 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 8

Population: Full Analysis Set (FAS) included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity [API] and stool frequency [SF] or consistency [SC]) for greater than or equal to (>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for stool frequency was defined as increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with baseline for Cohort C and for stool consistency was defined as decrease at least 50% in the proportion of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline for Cohort D. Participants with <4 weeks available were considered non-responders.

Outcome measures

Measure	Cohort C: Blautix n=76 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=82 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=94 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=101 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Percentage of Participants With Overall Response	25.0 Percentage of Participants	17.1 Percentage of Participants	23.4 Percentage of Participants	17.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline up to follow-up visit (up to Week 14)

Population: Safety analysis set (SAF) included all participants randomized into the study who received at least one dose of Blautix or Placebo.

An adverse event (AE) was any untoward medical occurrence in a participant administered study medication and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened in severity on or after the start date of the study treatment and includes all AEs recorded through the follow-up visit. A treatment-related TEAE was a TEAE possibly related to the study treatment.

Outcome measures

Measure	Cohort C: Blautix n=80 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=84 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=97 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=104 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)	5 Participants	4 Participants	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at specified timepoint.

The subject global assessment of relief was collected weekly through the electronic clinical outcome assessment (eCOA) system. It was a comparison of how the participant has felt over the past week with regards to their IBS to the way they felt before entering the study. It was measured on a 5-point Likert scale with the following responses: Completely relieved; considerably relieved; somewhat relieved; unchanged; worse. The total score ranged from 0-20, where higher scores indicated worsening of condition.

Outcome measures

Measure	Cohort C: Blautix n=66 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=70 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=84 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=86 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Number of Participants With Response to Subject Global Assessment of Relief Week 1: Completely Relieved	0 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 1: Considerably Relieved	1 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 1: Somewhat Relieved	6 Participants	6 Participants	3 Participants	8 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 1: Unchanged	58 Participants	56 Participants	72 Participants	76 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 1: Worse	1 Participants	3 Participants	6 Participants	2 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 4: Completely Relieved	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 4: Considerably Relieved	13 Participants	7 Participants	13 Participants	14 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 4: Somewhat Relieved	31 Participants	31 Participants	26 Participants	24 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 4: Unchanged	17 Participants	19 Participants	28 Participants	28 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 4: Worse	1 Participants	5 Participants	4 Participants	4 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 8: Completely Relieved	2 Participants	3 Participants	5 Participants	3 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 8: Considerably Relieved	20 Participants	13 Participants	14 Participants	16 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 8: Somewhat Relieved	24 Participants	23 Participants	22 Participants	26 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 8: Unchanged	18 Participants	19 Participants	21 Participants	20 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 8: Worse	1 Participants	2 Participants	6 Participants	5 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 12: Completely Relieved	5 Participants	5 Participants	5 Participants	2 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 12: Considerably Relieved	6 Participants	11 Participants	10 Participants	5 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 12: Somewhat Relieved	13 Participants	17 Participants	14 Participants	16 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 12: Unchanged	14 Participants	16 Participants	19 Participants	24 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 12: Worse	2 Participants	3 Participants	2 Participants	5 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 13: Completely Relieved	4 Participants	4 Participants	4 Participants	3 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 13: Considerably Relieved	9 Participants	12 Participants	4 Participants	3 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 13: Somewhat Relieved	12 Participants	9 Participants	12 Participants	14 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 13: Unchanged	7 Participants	12 Participants	15 Participants	18 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 13: Worse	1 Participants	4 Participants	5 Participants	4 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 14: Completely Relieved	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 14: Considerably Relieved	2 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 14: Somewhat Relieved	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 14: Unchanged	0 Participants	5 Participants	8 Participants	4 Participants
Number of Participants With Response to Subject Global Assessment of Relief Week 14: Worse	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Stool consistency of each bowel movement was rated on 7-level Bristol Stool Chart where Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score range of 1 to 7 where, 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Change in percentage of days per week with at least 1 stool with a undesired stool consistency of 1 or 2 for Cohort C and 6 or 7 for Cohort D on the Bristol Stool Chart from baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) was reported.

Outcome measures

Measure	Cohort C: Blautix n=64 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=73 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=83 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=94 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 1	0.13 Percentage of days per week Standard Deviation 22.859	3.38 Percentage of days per week Standard Deviation 24.412	-25.67 Percentage of days per week Standard Deviation 28.078	-23.70 Percentage of days per week Standard Deviation 30.730
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 4	-4.23 Percentage of days per week Standard Deviation 24.470	-1.99 Percentage of days per week Standard Deviation 24.077	-32.43 Percentage of days per week Standard Deviation 33.627	-33.73 Percentage of days per week Standard Deviation 33.615
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 8	-5.93 Percentage of days per week Standard Deviation 26.705	-0.10 Percentage of days per week Standard Deviation 22.852	-40.36 Percentage of days per week Standard Deviation 37.595	-36.91 Percentage of days per week Standard Deviation 35.753
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 12	-5.66 Percentage of days per week Standard Deviation 23.063	1.06 Percentage of days per week Standard Deviation 27.027	-34.09 Percentage of days per week Standard Deviation 41.128	-42.13 Percentage of days per week Standard Deviation 31.500
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 13	10.88 Percentage of days per week Standard Deviation 26.517	-5.16 Percentage of days per week Standard Deviation 19.868	-29.38 Percentage of days per week Standard Deviation 35.002	-32.21 Percentage of days per week Standard Deviation 39.679
Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 14	-15.48 Percentage of days per week Standard Deviation 1.684	-2.98 Percentage of days per week Standard Deviation 15.994	-40.00 Percentage of days per week Standard Deviation 36.216	-38.10 Percentage of days per week Standard Deviation 36.608

SECONDARY outcome

Timeframe: Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Stool consistency of each bowel movement was assessed by participants using the 7-point BSFS from 1 to 7 where Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Lower numbers represented more formed stools and higher numbers represented less formed stools. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Cohort C: Blautix n=63 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=70 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=83 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=94 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 1	15.05 Percent Change Standard Deviation 126.940	27.65 Percent Change Standard Deviation 129.217	32.30 Percent Change Standard Deviation 36.887	-27.27 Percent Change Standard Deviation 38.590
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 4	-6.36 Percent Change Standard Deviation 122.165	-7.18 Percent Change Standard Deviation 112.425	-40.14 Percent Change Standard Deviation 42.757	-40.60 Percent Change Standard Deviation 40.128
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 8	-12.00 Percent Change Standard Deviation 145.174	-4.64 Percent Change Standard Deviation 103.202	-49.32 Percent Change Standard Deviation 45.798	-42.64 Percent Change Standard Deviation 39.801
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 12	-7.45 Percent Change Standard Deviation 125.537	14.75 Percent Change Standard Deviation 144.064	-36.96 Percent Change Standard Deviation 50.023	-49.94 Percent Change Standard Deviation 34.638
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 13	41.07 Percent Change Standard Deviation 143.017	-40.31 Percent Change Standard Deviation 89.914	-33.29 Percent Change Standard Deviation 40.067	-35.91 Percent Change Standard Deviation 44.635
Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Percent Change at Week 14	-100.00 Percent Change Standard Deviation 0.000	-25.00 Percent Change Standard Deviation 106.066	-52.50 Percent Change Standard Deviation 49.319	-43.53 Percent Change Standard Deviation 44.353

SECONDARY outcome

Timeframe: Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Stool frequency was defined as a sum of weekly CSBMs. Participants were reminded to rate all their bowel movements in the Bristol Stool Chart (BSC) before answering the question. Stool types were assessed using the 7-point BSFS where 1 = separate hard lumps, like nuts (hard to pass), 2 = sausage-shaped but lumpy, 3 = like a sausage but with cracks on the surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges (passed easily), 6 = fluffy pieces with ragged edges, a mushy stool, 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Weekly stool frequency was based on the daily stool frequency which was calculated as follows: if there was 1 or more entry for BSC, the number of BSC entries was summed up. If on that day laxative was used, the daily stool frequency was set to 0. If an answer to CSBMs, but no BSC entry was provided, the daily stool frequency was set to 0 on that day.

Outcome measures

Measure	Cohort C: Blautix n=64 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=73 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=83 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=94 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 1	1.33 complete spontaneous bowel movements Standard Deviation 2.202	1.61 complete spontaneous bowel movements Standard Deviation 2.416	-1.07 complete spontaneous bowel movements Standard Deviation 2.441	-1.02 complete spontaneous bowel movements Standard Deviation 3.119
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 4	2.14 complete spontaneous bowel movements Standard Deviation 2.348	1.87 complete spontaneous bowel movements Standard Deviation 2.809	-1.60 complete spontaneous bowel movements Standard Deviation 2.543	-1.83 complete spontaneous bowel movements Standard Deviation 3.389
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 8	2.00 complete spontaneous bowel movements Standard Deviation 2.289	2.42 complete spontaneous bowel movements Standard Deviation 2.751	-2.59 complete spontaneous bowel movements Standard Deviation 3.012	-1.97 complete spontaneous bowel movements Standard Deviation 3.048
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 12	1.76 complete spontaneous bowel movements Standard Deviation 2.547	2.18 complete spontaneous bowel movements Standard Deviation 2.762	-2.29 complete spontaneous bowel movements Standard Deviation 2.599	-2.43 complete spontaneous bowel movements Standard Deviation 3.299
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 13	2.09 complete spontaneous bowel movements Standard Deviation 2.489	1.98 complete spontaneous bowel movements Standard Deviation 2.539	-2.05 complete spontaneous bowel movements Standard Deviation 3.242	-1.77 complete spontaneous bowel movements Standard Deviation 2.804
Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) Change at Week 14	2.56 complete spontaneous bowel movements Standard Deviation 0.507	1.19 complete spontaneous bowel movements Standard Deviation 0.860	-4.71 complete spontaneous bowel movements Standard Deviation 2.626	-3.54 complete spontaneous bowel movements Standard Deviation 4.063

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Participants were asked to complete a QOL of 34 items which formed 8 scales: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items), food avoidance (3 items), social reaction (4 items), sexual (2 items), and relationships (3 items). All 8 scales were rated on a five-point response scale where, 1= not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely or a great deal. Scores for individual items were averaged to obtain a total score for each sub-scale of IBSQoL. Total and subscale scores were transformed to a 0 to 100 point scale (0=lowest score, 100=highest possible score) with higher scores indicating better IBS-specific quality of life. Transformed scale score = (Sum of the items-lowest possible score/Possible raw score range)∗100. A positive change from baseline indicates improved quality of life.

Outcome measures

Measure	Cohort C: Blautix n=41 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=41 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=47 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=64 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Total score	5.67 Score on a Scale Standard Deviation 16.858	5.79 Score on a Scale Standard Deviation 21.908	5.62 Score on a Scale Standard Deviation 18.087	5.93 Score on a Scale Standard Deviation 13.113
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Dysphoria score	5.95 Score on a Scale Standard Deviation 20.561	5.34 Score on a Scale Standard Deviation 22.881	9.17 Score on a Scale Standard Deviation 22.627	5.81 Score on a Scale Standard Deviation 17.429
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Interference with activity Score	4.79 Score on a Scale Standard Deviation 16.952	6.71 Score on a Scale Standard Deviation 22.633	7.54 Score on a Scale Standard Deviation 18.230	8.26 Score on a Scale Standard Deviation 16.008
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Body Image Score	4.88 Score on a Scale Standard Deviation 23.779	7.62 Score on a Scale Standard Deviation 23.239	5.83 Score on a Scale Standard Deviation 20.703	4.10 Score on a Scale Standard Deviation 17.860
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Health Worry Score	10.98 Score on a Scale Standard Deviation 23.082	10.57 Score on a Scale Standard Deviation 26.940	6.85 Score on a Scale Standard Deviation 19.727	7.55 Score on a Scale Standard Deviation 19.056
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Food Avoidance Score	6.50 Score on a Scale Standard Deviation 20.625	4.88 Score on a Scale Standard Deviation 29.461	5.56 Score on a Scale Standard Deviation 19.624	7.55 Score on a Scale Standard Deviation 19.960
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Social Reaction Score	4.12 Score on a Scale Standard Deviation 16.922	2.44 Score on a Scale Standard Deviation 24.402	0.42 Score on a Scale Standard Deviation 23.963	6.64 Score on a Scale Standard Deviation 14.935
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Sexual Score	7.32 Score on a Scale Standard Deviation 29.445	1.52 Score on a Scale Standard Deviation 24.716	-0.56 Score on a Scale Standard Deviation 20.288	0.39 Score on a Scale Standard Deviation 19.284
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Relationships Score	2.85 Score on a Scale Standard Deviation 21.214	5.89 Score on a Scale Standard Deviation 26.170	1.30 Score on a Scale Standard Deviation 23.500	2.73 Score on a Scale Standard Deviation 17.509
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Total score	12.27 Score on a Scale Standard Deviation 20.969	8.09 Score on a Scale Standard Deviation 18.318	11.89 Score on a Scale Standard Deviation 20.933	8.37 Score on a Scale Standard Deviation 18.043
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Dysphoria score	13.40 Score on a Scale Standard Deviation 21.044	7.59 Score on a Scale Standard Deviation 20.085	14.23 Score on a Scale Standard Deviation 26.241	12.21 Score on a Scale Standard Deviation 20.403
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Interference with activity Score	10.15 Score on a Scale Standard Deviation 26.120	10.31 Score on a Scale Standard Deviation 21.529	15.12 Score on a Scale Standard Deviation 22.944	8.96 Score on a Scale Standard Deviation 20.247
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Body Image Score	12.83 Score on a Scale Standard Deviation 22.696	8.93 Score on a Scale Standard Deviation 18.890	13.70 Score on a Scale Standard Deviation 22.217	7.43 Score on a Scale Standard Deviation 23.096
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Health Worry Score	17.32 Score on a Scale Standard Deviation 27.834	12.38 Score on a Scale Standard Deviation 22.810	7.80 Score on a Scale Standard Deviation 22.947	7.23 Score on a Scale Standard Deviation 19.614
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Food Avoidance Score	17.54 Score on a Scale Standard Deviation 27.522	7.38 Score on a Scale Standard Deviation 29.412	14.01 Score on a Scale Standard Deviation 22.327	6.60 Score on a Scale Standard Deviation 24.534
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Social Reaction Score	10.69 Score on a Scale Standard Deviation 21.401	3.21 Score on a Scale Standard Deviation 17.960	8.78 Score on a Scale Standard Deviation 24.473	7.55 Score on a Scale Standard Deviation 20.669
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Sexual Score	10.53 Score on a Scale Standard Deviation 24.406	3.57 Score on a Scale Standard Deviation 22.600	3.46 Score on a Scale Standard Deviation 26.797	3.30 Score on a Scale Standard Deviation 26.420
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Relationships Score	6.36 Score on a Scale Standard Deviation 19.800	9.05 Score on a Scale Standard Deviation 22.721	7.45 Score on a Scale Standard Deviation 21.858	5.35 Score on a Scale Standard Deviation 20.155
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Total score	15.55 Score on a Scale Standard Deviation 21.368	8.09 Score on a Scale Standard Deviation 16.647	7.93 Score on a Scale Standard Deviation 23.919	10.80 Score on a Scale Standard Deviation 19.950
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Dysphoria score	15.99 Score on a Scale Standard Deviation 23.957	8.07 Score on a Scale Standard Deviation 17.236	10.47 Score on a Scale Standard Deviation 30.336	11.43 Score on a Scale Standard Deviation 21.236
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Interference with activity Score	14.50 Score on a Scale Standard Deviation 23.195	12.00 Score on a Scale Standard Deviation 21.278	9.75 Score on a Scale Standard Deviation 25.417	14.94 Score on a Scale Standard Deviation 26.243
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Body Image Score	17.10 Score on a Scale Standard Deviation 21.777	9.38 Score on a Scale Standard Deviation 17.772	8.95 Score on a Scale Standard Deviation 24.409	9.38 Score on a Scale Standard Deviation 25.200
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Health Worry Score	19.36 Score on a Scale Standard Deviation 28.701	9.26 Score on a Scale Standard Deviation 23.382	10.14 Score on a Scale Standard Deviation 23.663	14.25 Score on a Scale Standard Deviation 18.371
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Food Avoidance Score	16.91 Score on a Scale Standard Deviation 23.524	9.72 Score on a Scale Standard Deviation 21.776	7.43 Score on a Scale Standard Deviation 24.594	9.21 Score on a Scale Standard Deviation 26.408
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Social Reaction Score	13.79 Score on a Scale Standard Deviation 24.942	1.04 Score on a Scale Standard Deviation 15.917	6.59 Score on a Scale Standard Deviation 27.676	9.38 Score on a Scale Standard Deviation 23.554
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Sexual Score	15.07 Score on a Scale Standard Deviation 26.253	3.13 Score on a Scale Standard Deviation 23.599	-1.69 Score on a Scale Standard Deviation 27.507	4.93 Score on a Scale Standard Deviation 25.425
Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Relationships Score	12.25 Score on a Scale Standard Deviation 22.774	7.18 Score on a Scale Standard Deviation 22.900	2.03 Score on a Scale Standard Deviation 24.799	5.26 Score on a Scale Standard Deviation 22.041

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Participants were asked to complete a questionnaire on the severity of abdominal distension and pain, frequency of abdominal pain, dissatisfaction with bowel habits, and interference of IBS symptoms with daily life. The IBS-SSS was measured on a Visual Analog Scale (VAS scale) in combination with reported numeric values which equated to an overall score. The scale range was from 0 (no symptoms) to 500 (maximum severity). Participants were categorized as having mild (74-174), moderate (175-299), or severe (>300) IBS symptoms based on symptomology. Higher scores were indicative of greater disease severity (worse outcome). A negative change from Baseline indicates improvement.

Outcome measures

Measure	Cohort C: Blautix n=77 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=81 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=83 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=93 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4	-128.87 Score on a Scale Standard Deviation 143.885	-141.30 Score on a Scale Standard Deviation 139.439	-125.75 Score on a Scale Standard Deviation 135.258	-100.97 Score on a Scale Standard Deviation 114.939
Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8	-168.46 Score on a Scale Standard Deviation 157.300	-173.53 Score on a Scale Standard Deviation 155.253	-143.55 Score on a Scale Standard Deviation 143.781	-133.63 Score on a Scale Standard Deviation 139.290
Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit	-142.49 Score on a Scale Standard Deviation 149.678	-160.66 Score on a Scale Standard Deviation 150.174	-113.47 Score on a Scale Standard Deviation 135.064	-104.76 Score on a Scale Standard Deviation 146.447

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

Population: FAS included all participants in the safety analysis set who were appropriately randomized into the study. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified time points.

Participants were asked to complete the HADS which was a 14-item scale (7 items- anxiety and 7 items-depression) that generated ordinal data. Each question was rated on a scale from 0 - 3. The outcome of the HADS questionnaire was two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Cohort C: Blautix n=41 Participants Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=41 Participants Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=47 Participants Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=64 Participants Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Anxiety total score	-0.02 Score on a Scale Standard Deviation 2.612	0.22 Score on a Scale Standard Deviation 2.954	0.09 Score on a Scale Standard Deviation 2.827	-0.27 Score on a Scale Standard Deviation 3.243
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 4: Depression total score	0.24 Score on a Scale Standard Deviation 3.527	-0.29 Score on a Scale Standard Deviation 3.303	0.22 Score on a Scale Standard Deviation 2.566	0.00 Score on a Scale Standard Deviation 2.410
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Anxiety total score	0.08 Score on a Scale Standard Deviation 2.981	-0.09 Score on a Scale Standard Deviation 3.320	-0.32 Score on a Scale Standard Deviation 3.251	-0.40 Score on a Scale Standard Deviation 3.213
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Week 8: Depression total score	-0.18 Score on a Scale Standard Deviation 3.432	-0.06 Score on a Scale Standard Deviation 3.556	0.19 Score on a Scale Standard Deviation 2.787	-0.36 Score on a Scale Standard Deviation 3.169
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Anxiety total score	-0.53 Score on a Scale Standard Deviation 3.360	0.06 Score on a Scale Standard Deviation 2.714	-0.14 Score on a Scale Standard Deviation 3.029	-0.55 Score on a Scale Standard Deviation 3.375
Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14) Change at Follow-up visit: Depression total score	-0.85 Score on a Scale Standard Deviation 3.735	-0.14 Score on a Scale Standard Deviation 2.939	0.51 Score on a Scale Standard Deviation 3.024	-0.68 Score on a Scale Standard Deviation 2.886

Adverse Events

Cohort C: Blautix

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Cohort C: Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort D: Blautix

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Cohort D: Placebo

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort C: Blautix n=80 participants at risk Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=84 participants at risk Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=97 participants at risk Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=104 participants at risk Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Cellulitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.

Other adverse events

Measure	Cohort C: Blautix n=80 participants at risk Participants diagnosed with IBS-C received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort C: Placebo n=84 participants at risk Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.	Cohort D: Blautix n=97 participants at risk Participants diagnosed with IBS-D received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) was 10\^10 to 10\^11 MPN.	Cohort D: Placebo n=104 participants at risk Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Abnormal faeces	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Anal fissure	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Flatulence	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Gastritis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Glossodynia	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
General disorders Fatigue	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.6% 3/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
General disorders Influenza like illness	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
General disorders Chest pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
General disorders Early satiety	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
General disorders Thirst	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.1% 2/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Toothache	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Nervous system disorders Headache	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.4% 2/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	4.1% 4/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	4.8% 5/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Nervous system disorders Dizziness	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Nervous system disorders Hypoaesthesia	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Nervous system disorders Tremor	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Ligament sprain	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Ankle fracture	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Injury, poisoning and procedural complications Sunburn	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Psychiatric disorders Insomnia	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.1% 2/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Psychiatric disorders Anxiety	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Psychiatric disorders Irritability	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Renal and urinary disorders Dysuria	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Renal and urinary disorders Haematuria	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Renal and urinary disorders Pollakiuria	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Renal and urinary disorders Urine odour abnormal	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Skin and subcutaneous tissue disorders Brachioradial pruritus	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Investigations Alanine aminotransferase increased	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Investigations C-reactive protein increased	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Investigations Gamma-glutamyltransferase increased	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Investigations Neutrophil count decreased	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Investigations White blood cell count decreased	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Vascular disorders Hot flush	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Vascular disorders Hypertension	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Blood and lymphatic system disorders Normocytic anaemia	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Cardiac disorders Palpitations	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Metabolism and nutrition disorders Hyperglycaemia	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Reproductive system and breast disorders Breast mass	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Ear and labyrinth disorders Tinnitus	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Vomiting	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Upper respiratory tract infection	5.0% 4/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.6% 3/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.1% 3/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.8% 4/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Gastroenteritis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	4.1% 4/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.8% 4/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Nasopharyngitis	2.5% 2/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	5.2% 5/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Cellulitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Urinary tract infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Vulvovaginal candidiasis	2.5% 2/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Bronchitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Influenza	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Pharyngitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Tooth infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Acute sinusitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Ear infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Herpes zoster	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Lice infestation	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Lower respiratory tract infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Oral herpes	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Otitis media	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Rhinitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Sinusitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Tonsillitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Vaginal infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Viral infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Viral rhinitis	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Abdominal pain	2.5% 2/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.1% 2/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.9% 3/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Diarrhoea	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	5.2% 5/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Constipation	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.2% 1/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Dyspepsia	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.1% 3/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.2% 1/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.4% 2/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	3.1% 3/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Haemorrhoids	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	2.4% 2/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.96% 1/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Nausea	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.0% 1/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.
Gastrointestinal disorders Abdominal distension	0.00% 0/80 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/84 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	0.00% 0/97 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.	1.9% 2/104 • Baseline up to follow-up visit (up to Week 14) SAF included all participants randomized into the study who received at least one dose of Blautix or Placebo.

Additional Information

Programme Development Director

4D pharma plc

Phone: +4401138950130

Email: clinicaltrials@4dpharmaplc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place