Fecal Microbiota Transplantation for Pouchitis
Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis
McMaster University
34 participants
Apr 17, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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
Exclusion Criteria4
- Participating in another clinical trial
- Unable to give informed consent
- Severe comorbid medical illness
- Concomitant Clostridium difficile infection
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Interventions
Stool from healthy donor administered via enema
Saline with food coloring administered via enema
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03545386