Trial Outcomes & Findings for Dietary Supplement With and Without a Probiotic and/or Antibiotic (NCT NCT05141903)
NCT ID: NCT05141903
Last Updated: 2025-02-17
Results Overview
Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.
Recruitment status
COMPLETED
Target enrollment
92 participants
Primary outcome timeframe
Baseline, Day, 5, 14, 35
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Antibiotics Alone
Antibiotics (Only)
|
Antibiotics, Probiotic, HMO
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotic
Antibiotics, Probiotic
|
Antibiotics, Probiotic, HMO, Food
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotic, Food
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
17
|
17
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Antibiotics Alone
Antibiotics (Only)
|
Antibiotics, Probiotic, HMO
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotic
Antibiotics, Probiotic
|
Antibiotics, Probiotic, HMO, Food
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotic, Food
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dietary Supplement With and Without a Probiotic and/or Antibiotic
Baseline characteristics by cohort
| Measure |
Antibiotics Alone
n=19 Participants
D1-D5: Antibiotics (3x daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
|
Antibiotics, Probiotic, HMO
n=19 Participants
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
HMO Concentrate: Concentrated milk fortifiers from donor human milk
Probiotic: B. infantis
|
Antibiotics, Probiotic
n=18 Participants
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Probiotic: B. infantis
|
Antibiotics, Probiotic, HMO, Food
n=18 Participants
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
HMO Concentrate: Concentrated milk fortifiers from donor human milk
Probiotic: B. infantis
Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
|
Antibiotics, Probiotic, Food
n=18 Participants
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Probiotic: B. infantis
Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
68 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
18 participants
n=5 Participants
|
18 participants
n=4 Participants
|
18 participants
n=21 Participants
|
92 participants
n=8 Participants
|
|
Baseline Levels of B. Infantis
|
27.00 copies/ng DNA
STANDARD_DEVIATION 0.00 • n=5 Participants
|
31.25 copies/ng DNA
STANDARD_DEVIATION 82.27 • n=7 Participants
|
27.00 copies/ng DNA
STANDARD_DEVIATION 0.00 • n=5 Participants
|
27.00 copies/ng DNA
STANDARD_DEVIATION 0.00 • n=4 Participants
|
27.00 copies/ng DNA
STANDARD_DEVIATION 0.00 • n=21 Participants
|
27.8 copies/ng DNA
STANDARD_DEVIATION 36.2 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day, 5, 14, 35Population: All participants assigned to an arm and were able to provide adequate evaluable samples for DNA analysis
Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=17 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
n=17 Participants
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
n=18 Participants
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
n=18 Participants
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Baseline
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
31.25 copies/ng DNA
Standard Deviation 82.27
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
|
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Day 5
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
383.41 copies/ng DNA
Standard Deviation 862.67
|
535.35 copies/ng DNA
Standard Deviation 708.21
|
204.11 copies/ng DNA
Standard Deviation 312.05
|
431.26 copies/ng DNA
Standard Deviation 883.43
|
|
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Day 14
|
28.08 copies/ng DNA
Standard Deviation 6.87
|
26877.59 copies/ng DNA
Standard Deviation 69845.62
|
1868.09 copies/ng DNA
Standard Deviation 10150.73
|
21736.64 copies/ng DNA
Standard Deviation 50622.14
|
45466.96 copies/ng DNA
Standard Deviation 81975.89
|
|
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Day 35
|
27.00 copies/ng DNA
Standard Deviation 0.00
|
311.22 copies/ng DNA
Standard Deviation 14917.81
|
77.15 copies/ng DNA
Standard Deviation 1857.25
|
88.78 copies/ng DNA
Standard Deviation 1249.73
|
170.03 copies/ng DNA
Standard Deviation 5638.54
|
SECONDARY outcome
Timeframe: Baseline-28 daysPopulation: Analysis of Group 1 control vs Group 2 +HMO to assess impact of study product. Subjects who provided evaluable samples for all time points were evaluated for clinical pharmacology endpoints. DATA WERE COLLECTED FOR ONLY GROUPS 1 AND 2.
Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=17 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
LAP-TGFB - baseline
|
34.3 ng/mL
Standard Deviation 8.1
|
37.6 ng/mL
Standard Deviation 9.6
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
LAP-TGFB - Day 5
|
34.3 ng/mL
Standard Deviation 7.7
|
34.6 ng/mL
Standard Deviation 7.8
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
LAP-TGFB - Day 14
|
29.7 ng/mL
Standard Deviation 9.0
|
34.7 ng/mL
Standard Deviation 8.1
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
LAP-TGFB - Day 28
|
30.2 ng/mL
Standard Deviation 9.3
|
32.9 ng/mL
Standard Deviation 5.9
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MCP1 - Baseline
|
405.6 ng/mL
Standard Deviation 211.3
|
399.7 ng/mL
Standard Deviation 253.3
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MCP1 - Day 5
|
416.6 ng/mL
Standard Deviation 214.0
|
401.8 ng/mL
Standard Deviation 215.5
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MCP1 - Day 14
|
476.8 ng/mL
Standard Deviation 243.8
|
411.1 ng/mL
Standard Deviation 199.1
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MCP1 - Day 28
|
464.3 ng/mL
Standard Deviation 250.6
|
433.8 ng/mL
Standard Deviation 187.3
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MIP - Baseline
|
385.7 ng/mL
Standard Deviation 106.9
|
358.2 ng/mL
Standard Deviation 228.7
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MIP - Day 5
|
429 ng/mL
Standard Deviation 129.9
|
391.9 ng/mL
Standard Deviation 231.0
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MIP - Day 14
|
383.6 ng/mL
Standard Deviation 226.1
|
361.6 ng/mL
Standard Deviation 224.2
|
—
|
—
|
—
|
|
Changes in Immune Markers Assessment at Day 5, 14 and 28
MIP - Day 28
|
315.1 ng/mL
Standard Deviation 134.5
|
322.0 ng/mL
Standard Deviation 226.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 - 35Population: All participants assigned to an arm and were able to provide blood pressure data.
Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \[BP\]). Descriptive statistics performed by dose group and visit.
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=19 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
n=18 Participants
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
n=18 Participants
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
n=18 Participants
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Blood Pressures of Subjects From Baseline to Day 35
Systolic Blood Pressure (mmHg) - Baseline
|
123 mmHg
Standard Deviation 13.8
|
125 mmHg
Standard Deviation 19
|
127 mmHg
Standard Deviation 15.2
|
117 mmHg
Standard Deviation 11
|
121 mmHg
Standard Deviation 15.6
|
|
Blood Pressures of Subjects From Baseline to Day 35
Systolic Blood Pressure (mmHg) - Day 35
|
128 mmHg
Standard Deviation 16.6
|
127 mmHg
Standard Deviation 17.3
|
130 mmHg
Standard Deviation 18.7
|
121 mmHg
Standard Deviation 14.8
|
120 mmHg
Standard Deviation 18.1
|
|
Blood Pressures of Subjects From Baseline to Day 35
Diastolic Blood Pressure (mmHg) - Baseline
|
75 mmHg
Standard Deviation 5.6
|
77 mmHg
Standard Deviation 11.7
|
76 mmHg
Standard Deviation 9.7
|
71 mmHg
Standard Deviation 8.5
|
73 mmHg
Standard Deviation 7.9
|
|
Blood Pressures of Subjects From Baseline to Day 35
Diastolic Blood Pressure (mmHg) - Day 35
|
75 mmHg
Standard Deviation 7.4
|
74 mmHg
Standard Deviation 10
|
77 mmHg
Standard Deviation 12.1
|
73 mmHg
Standard Deviation 10
|
71 mmHg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Day 0-35Population: All participants assigned to an arm and were able to provide heart rate data.
Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=19 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
n=18 Participants
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
n=18 Participants
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
n=18 Participants
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Heart Rates of Subjects From Baseline to Day 35
Heart rate - Baseline
|
66 beats per minute
Standard Deviation 10.9
|
66 beats per minute
Standard Deviation 8.7
|
68 beats per minute
Standard Deviation 8.1
|
70 beats per minute
Standard Deviation 11.9
|
71 beats per minute
Standard Deviation 7.4
|
|
Heart Rates of Subjects From Baseline to Day 35
Heart rate - Day 35
|
69 beats per minute
Standard Deviation 10.9
|
72 beats per minute
Standard Deviation 16.2
|
73 beats per minute
Standard Deviation 11.1
|
66 beats per minute
Standard Deviation 11.9
|
68 beats per minute
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Day 0-35Population: All participants assigned to an arm and were able to provide respiration rates
Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=19 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
n=18 Participants
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
n=18 Participants
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
n=18 Participants
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Respiratory Rates of Subjects From Baseline to Day 35
Respirations - Baseline
|
15 breaths per minute
Standard Deviation 1.6
|
15 breaths per minute
Standard Deviation 1.1
|
15 breaths per minute
Standard Deviation 1.2
|
15 breaths per minute
Standard Deviation 1.0
|
16 breaths per minute
Standard Deviation 1.2
|
|
Respiratory Rates of Subjects From Baseline to Day 35
Respirations - Day 35
|
15 breaths per minute
Standard Deviation 1.1
|
15 breaths per minute
Standard Deviation 1.4
|
15 breaths per minute
Standard Deviation 1.7
|
15 breaths per minute
Standard Deviation 1.1
|
14 breaths per minute
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Day 0-35Population: All participants assigned to an arm and were able to provide temperatures.
Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).
Outcome measures
| Measure |
Antibiotics Alone
n=19 Participants
Antibiotics (Only)
|
Antibiotics, Probiotics, HMO
n=19 Participants
Antibiotics, Probiotic, HMO Concentrate
|
Antibiotics Probiotics
n=18 Participants
Antibiotics and Probiotic
|
Antibiotics, Probiotics, HMO, Food
n=18 Participants
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Antibiotics, Probiotics, Food
n=18 Participants
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Temperatures of Subjects From Baseline to Day 35
Temperature - Baseline
|
36.8 deg C
Standard Deviation 0.21
|
36.7 deg C
Standard Deviation 0.24
|
36.9 deg C
Standard Deviation 0.24
|
36.8 deg C
Standard Deviation 0.28
|
36.9 deg C
Standard Deviation 0.22
|
|
Temperatures of Subjects From Baseline to Day 35
Temperature - Day 35
|
36.9 deg C
Standard Deviation 0.14
|
36.8 deg C
Standard Deviation 0.19
|
36.8 deg C
Standard Deviation 0.13
|
36.8 deg C
Standard Deviation 0.28
|
36.8 deg C
Standard Deviation 0.28
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=19 participants at risk
Antibiotics (Only)
|
Arm 2
n=19 participants at risk
Antibiotics, Probiotic, HMO Concentrate
|
Arm 3
n=18 participants at risk
Antibiotics, Probiotic
|
Arm 4
n=18 participants at risk
Antibiotics, Probiotic, HMO concentrate, Food Supplement
|
Arm 5
n=18 participants at risk
Antibiotics, Probiotic, Food Supplement
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
11.1%
2/18 • Number of events 2 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
15.8%
3/19 • Number of events 3 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
11.1%
2/18 • Number of events 2 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
GI Hypermotility
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Dry Lips
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
11.1%
2/18 • Number of events 2 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Infections and infestations
COVID-19
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Investigations
SARS-COV-2 Test Positive
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
5.6%
1/18 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • up to 7 weeks (D1 through D35)
|
0.00%
0/19 • up to 7 weeks (D1 through D35)
|
11.1%
2/18 • Number of events 2 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
0.00%
0/18 • up to 7 weeks (D1 through D35)
|
Additional Information
Dr. David Rechtman VP, Medical Affairs
Prolacta Bioscience
Phone: 8887765228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place