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Fecal Microbiota Transplantation for Pouchitis

Pouchitis

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

McMaster University
McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Neeraj Narula

[email protected]
9055212100
Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT03545386