Trial Outcomes & Findings for Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO (NCT NCT03834051)

Last Updated: 2024-03-18

Results Overview

Evaluate the Ulcerative Colitis Disease Activity Index from baseline 4 weeks, 12 weeks and 1 year following FMT using partial-MAYO score. Partial-MAYO is a validated scoring system to determine the activity of UC. it uses three non-invasive components (stool frequency, rectal bleeding and physician's global assessment. Each of the 3 clinical parameters is assigned a score from 0 to 3 according to the clinical evaluation with a total possible score of 9. Higher the score, more severe the disease; score of 0 - 1 is considered in remission; 2 - 4 mild; 5 - 7 moderate; \> 7 severe colitis.

Recruitment status

TERMINATED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

1 year

Results posted on

2024-03-18

Participant Flow

Participants with IBD or IBS were recruited to receive FMT via rectal administration in the outpatient medical clinic.

Participant milestones

Participant milestones
Measure	Open Label Fecal Microbiota Transplantation Fecal Microbiota Transplantation: Fecal Microbiota Transplantation Rectal Administration Open Label
Overall Study STARTED	33
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=33 Participants Fecal Microbiota Transplantation Fecal Microbiota Transplantation: Fecal Microbiota Transplantation Rectal Administration Open Label
Age, Continuous Ulcerative colitis	36.36 years STANDARD_DEVIATION 12.06 • n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Age, Continuous Irritable bowel syndrome	52.94 years STANDARD_DEVIATION 15.20 • n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Age, Continuous Crohn's disease	46.33 years STANDARD_DEVIATION 9.45 • n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Age, Continuous Microscopic colitis	54.67 years STANDARD_DEVIATION 12.06 • n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Ulcerative colitis · Female	7 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Ulcerative colitis · Male	4 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Irritable bowel syndrome · Female	9 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Irritable bowel syndrome · Male	7 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Crohn's disease · Female	1 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Crohn's disease · Male	2 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Microscopic colitis · Female	3 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Sex: Female, Male Microscopic colitis · Male	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · American Indian or Alaska Native	0 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · Asian	1 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · Black or African American	0 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · White	10 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · More than one race	0 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Ulcerative colitis · Unknown or Not Reported	0 Participants n=11 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · American Indian or Alaska Native	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · Asian	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · Black or African American	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · White	16 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · More than one race	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Irritable bowel syndrome · Unknown or Not Reported	0 Participants n=16 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · American Indian or Alaska Native	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · Asian	1 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · Black or African American	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · White	2 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · More than one race	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Crohn's disease · Unknown or Not Reported	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · American Indian or Alaska Native	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · Asian	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · Black or African American	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · White	3 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · More than one race	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Race (NIH/OMB) Microscopic colitis · Unknown or Not Reported	0 Participants n=3 Participants • 33 participants were enrolled for this study. 11 had ulcerative colitis 16 had irritable bowel syndrome 3 had Crohn's disease 3 had microscopic colitis
Region of Enrollment Canada	33 Participants n=33 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Baseline partial-MAYO score for UC

Outcome measures

Outcome measures
Measure	Baseline Partial-MAYO Score n=11 Participants active UC, partial-MAYO score at baseline prior to receiving FMT
Efficacy of FMT in Active Ulcerative Colitis Baseline partial-MAYO score	4.81 partial-MAYO Score Standard Deviation 2.36
Efficacy of FMT in Active Ulcerative Colitis week 12 post-FMT partial-MAYO score	2.09 partial-MAYO Score Standard Deviation 1.81
Efficacy of FMT in Active Ulcerative Colitis year 1 post-FMT partial-MAYO score	2.00 partial-MAYO Score Standard Deviation 1.95
Efficacy of FMT in Active Ulcerative Colitis week 4 post-FMT partial-MAYO score	2.91 partial-MAYO Score Standard Deviation 2.07

PRIMARY outcome

Timeframe: 1 year

Population: IBS patients with ROME IV diagnostic criteria

IBS severity symptom severity score scale (IBS-SSS) from baseline compared to following FMT in participants with irritable bowel syndrome. IBS-SSS is a validated instrument with a scoring system which produces a meaningful value that is both reproducible and sensitive to change. The instrument contains five questions across the following domains: pain; distension; bowel score and quality of life. Each question can generate a score from 0 to 100 using prompted visual analogue scales; the total scores can range from 0 to 500 with a maximum total score of 500. IBS-SSS is mild for scores 75 - 175; moderate 176 - 300 and severe if \> 300.

Outcome measures

Outcome measures
Measure	Baseline Partial-MAYO Score n=16 Participants active UC, partial-MAYO score at baseline prior to receiving FMT
Efficacy of FMT for Irritable Bowel Syndrome Baseline IBS severity scoring system (IBS-SSS)	358.73 score on a scale Standard Deviation 95.09
Efficacy of FMT for Irritable Bowel Syndrome year 1 post-FMT IBS severity scoring system	136.13 score on a scale Standard Deviation 58.97

PRIMARY outcome

Timeframe: 4 weeks

Population: There were no unexpected adverse events during the follow-up period

The Crohn's Disease Activity Index (CDAI) was measured at baseline and following FMT. CDAI is a validated instrument used in adults with active Crohn's disease. The index consists of eight factors, 2 of which are subjective: stool habits; pain; general well being; features of extra intestinal disease; use of opiates for diarrhea; abdominal mass; hematocrit (hct); and percentage of body weight below standard. Scores range from 0 to \~ 600: \> 450 is severe disease; 220 - 450 moderately active disease; 150 - 219 mildly active disease. Clinical remission is defined as a CDAI score \<150, clinical response is either a CDAI score \<150 or a CDAI reduction of ≥100 from baseline.

Outcome measures

Outcome measures
Measure	Baseline Partial-MAYO Score n=3 Participants active UC, partial-MAYO score at baseline prior to receiving FMT
Efficacy of FMT in Crohn's Disease Week 4 CDAI Mean Score	123 score on a scale Interval 105.0 to 142.0
Efficacy of FMT in Crohn's Disease Baseline Mean CDAI score	201.7 score on a scale Interval 157.0 to 257.0

PRIMARY outcome

Timeframe: Baseline to 4 weeks following FMT

Population: Participants with active microscopic colitis

Physician's global assessment and number of unformed bowel movements per 24 hours were employed at baseline and following FMT to assess response to FMT as these parameters used to determine MC treatment in clinical trials and care. For physician's global assessment, lower the score, lesser the disease activity: 0 = no disease activity; 1 = mild activity; 2 = moderate activity; 3 = severe disease activity

Outcome measures

Outcome measures
Measure	Baseline Partial-MAYO Score n=3 Participants active UC, partial-MAYO score at baseline prior to receiving FMT
Efficacy of FMT in Microscopic Colitis (MC) Based on Physician's Global Assessment Baseline Mean Physician Global Assessment	1.67 score on a scale Interval 1.0 to 2.0
Efficacy of FMT in Microscopic Colitis (MC) Based on Physician's Global Assessment week 4 Mean Physician Global Assessment	0.67 score on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: Baseline to 4 weeks following FMT

Population: participants with microscopic colitis

Outcome measures

Outcome measures
Measure	Baseline Partial-MAYO Score n=3 Participants active UC, partial-MAYO score at baseline prior to receiving FMT
Efficacy of FMT in Microscopic Colitis (MC) Based on Number of Unformed Bowel Movements in 24 Hours Baseline mean number of unformed bowel movements in 24 hours	7 number of unformed bowel movements/24 hr Interval 5.0 to 10.0
Efficacy of FMT in Microscopic Colitis (MC) Based on Number of Unformed Bowel Movements in 24 Hours Week 4 mean number of unformed bowel movements in 24 hours	2 number of unformed bowel movements/24 hr Interval 1.0 to 4.0

Adverse Events

Ulcerative Colitis

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Irritable Bowel Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crohn's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Microscopic Colitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ulcerative Colitis n=11 participants at risk Ulcerative colitis and adverse events Fecal Microbiota Transplantation: Fecal Microbiota Transplantation Rectal Administration Open Label	Irritable Bowel Syndrome n=16 participants at risk Irritable bowel syndrome and adverse events	Crohn's Disease n=3 participants at risk Crohn's Disease and adverse events	Microscopic Colitis n=3 participants at risk Microscopic Colitis and adverse events
Gastrointestinal disorders Colitis - colectomy	9.1% 1/11 • Number of events 1 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/16 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups
Gastrointestinal disorders chronic appendicitis - appendectomy	9.1% 1/11 • Number of events 1 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/16 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups

Other adverse events

Other adverse events
Measure	Ulcerative Colitis n=11 participants at risk Ulcerative colitis and adverse events Fecal Microbiota Transplantation: Fecal Microbiota Transplantation Rectal Administration Open Label	Irritable Bowel Syndrome n=16 participants at risk Irritable bowel syndrome and adverse events	Crohn's Disease n=3 participants at risk Crohn's Disease and adverse events	Microscopic Colitis n=3 participants at risk Microscopic Colitis and adverse events
General disorders fatigue	27.3% 3/11 • Number of events 3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/16 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups	0.00% 0/3 • Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant) Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups

Additional Information

Dr. Christine Lee

Vancouver Island Health Authority

Phone: 250 519 1898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place