Fecal Microbiota Transplantation for Pouchitis
Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis
1 other identifier
interventional
34
1 country
1
Brief Summary
This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedStudy Start
First participant enrolled
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedNovember 20, 2024
November 1, 2024
6.3 years
May 10, 2018
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Remission of pouchitis, defined as a pouchitis disease activity index (PDAI) score of <7, with a decreased from baseline PDAI score of 3 points
Comparison between FMT and placebo arms in remission rates
7 weeks
Secondary Outcomes (2)
compliance of patients who receive FMT
7 weeks
compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.
7 weeks
Study Arms (2)
FMT
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients aged 18 or over
- Active pouchitis defined as PDAI of 7-18 points
- Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
You may not qualify if:
- Participating in another clinical trial
- Unable to give informed consent
- Severe comorbid medical illness
- Concomitant Clostridium difficile infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8S4K1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2018
First Posted
June 4, 2018
Study Start
April 17, 2019
Primary Completion
July 31, 2025
Study Completion
September 30, 2025
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share