NCT03545386 Fecal Microbiota Transplantation for Pouchitis
| NCT ID | NCT03545386 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | McMaster University |
| Condition | Pouchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2019-04-17 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2019-04-17 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 or over 2. Active pouchitis defined as PDAI of 7-18 points 3. 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 Exclusion Criteria: 1. Participating in another clinical trial 2. Unable to give informed consent 3. Severe comorbid medical illness 4. Concomitant Clostridium difficile infection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03545386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Pouchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03545386 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03545386 currently recruiting?
Yes, NCT03545386 is actively recruiting participants. Contact the research team at narulan@mcmaster.ca for enrollment information.
Where is the NCT03545386 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT03545386 clinical trial?
NCT03545386 is sponsored by McMaster University. The trial plans to enroll 34 participants.