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 |
Trial Parameters
Eligibility Fast-Check
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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