Fecal Microbiota Transplantation for Pouchitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Pouchitis

In brief

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.

Key facts

Study ID

NCT03545386

Run by

McMaster University

People needed

34

Starts

2019-04-17

Expected to finish

2025-09-30

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• McMaster University — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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