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Trial Outcomes & Findings for FMT in Ulcerative Colitis-Associated Pouchitis (NCT NCT02049502)

NCT ID: NCT02049502

Last Updated: 2019-03-27

Results Overview

Improvement of clinical pouchitis symptoms based on the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse. These components include: stool frequency (number of stools), rectal bleeding, fecal urgency or abdominal cramps, or fever (temperature \>37.8C).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

3 months

Results posted on

2019-03-27

Participant Flow

Participant milestones

Participant milestones
Measure
Fecal Microbiota Transplant
fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FMT in Ulcerative Colitis-Associated Pouchitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fecal Microbiota Transplant
n=8 Participants
fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=93 Participants
Age, Categorical
>=65 years
1 Participants
n=93 Participants
Sex: Female, Male
Female
5 Participants
n=93 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
Race (NIH/OMB)
White
8 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
8 participants
n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Improvement of clinical pouchitis symptoms based on the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse. These components include: stool frequency (number of stools), rectal bleeding, fecal urgency or abdominal cramps, or fever (temperature \>37.8C).

Outcome measures

Outcome measures
Measure
Fecal Microbiota Transplant
n=8 Participants
fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy
Number of Patients Who Experienced Improvement of Pouchitis Symptoms
2 Participants

SECONDARY outcome

Timeframe: 3 months

16s ribosomal gene sequencing and metabolomic profile of the gut microbiota

Outcome measures

Outcome measures
Measure
Fecal Microbiota Transplant
n=8 Participants
fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy
Number of Patients With Favorable Microbiota Profile
3 Participants

Adverse Events

Fecal Microbiota Transplant

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Fecal Microbiota Transplant
n=8 participants at risk
fecal microbiota transplant biologically active human fecal microbiota: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy sigmoidoscopy
Gastrointestinal disorders
Abdominal pain
25.0%
2/8 • Number of events 2 • 3 months
Gastrointestinal disorders
Rectal bleeding
12.5%
1/8 • Number of events 1 • 3 months
Gastrointestinal disorders
Increase in stool frequency
12.5%
1/8 • Number of events 1 • 3 months
Reproductive system and breast disorders
Fever
12.5%
1/8 • Number of events 1 • 3 months
Nervous system disorders
Dizziness
12.5%
1/8 • Number of events 1 • 3 months

Additional Information

Dr. Shaffer

Emory University

Phone: 404-778-5033

Results disclosure agreements

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