Fecal Microbiota Transplantation for Pouchitis
Recruiting
Phase 2
Interventional Study
Pouchitis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 34 (estimated)
- Sponsor
- McMaster University · Other
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About This Trial
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 Locations
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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. Parti…
Contacts