Fecal Microbiota Transplantation for Active Pouchitis: A Randomized Controlled Trial
PI: Dr. Neeraj Narula, McMaster University
Co-Investigators
Dr. Paul Moayyedi, McMaster University
Dr. John Marshall, McMaster University
Dr. Geoffrey Nguyen, Mount Sinai Hospital
Dr. Vipul Jairath, Western University
Dr. Dina Kao, University of Alberta
Dr. Karen Wong, University of Alberta
Dr. Charles Bernstein, University of Manitoba
Dr. Jeffrey McCurdy, University of Ottawa
Purpose
The study objectives are to learn about a) if alteration of the microbiota through fecal microbiota transplantation in pouchitis helps improve disease symptoms and improve endoscopic inflammation; and b) understand the changes that occur in the gut bacteria during fecal transplantation.
Study Design
This is a randomized placebo-controlled trial involving multiple centres recruiting patients to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.
Participating Sites
McMaster University Medical Centre/Hamilton Health Sciences Centre, ON
University of Manitoba IBD Clinical and Research Centre in Winnipeg, MB
Ottawa Hospital Research Institute, ON
After participating in the six-week trial of FMT or placebo intervention once weekly, all patients are offered open-label FMT weekly by enema for six weeks. Responders to FMT are also offered maintenance treatment every 2 weeks subsequently, should they elect to continue, for up to an additional 40 weeks.
For more information on Inclusion & Exclusion Criteria, click here.
Targets
Anticipated sample size: 50
Start: April 1, 2019
Anticipated end: December 1, 2022
Reimbursement provided on a per patient basis. Additional sites are welcome! Please contact Neeraj Narula at neeraj.narula@medportal.ca.