Fecal Microbiota Transplantation for Pouchitis

Launched by MCMASTER UNIVERSITY · May 22, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) for patients with pouchitis, which is inflammation of the pouch created after surgery for conditions like ulcerative colitis. The trial aims to see if receiving this treatment once a week for six weeks can help more people with active pouchitis go into remission compared to those who receive a placebo (a treatment that looks the same but has no active ingredients). The study is taking place at McMaster University in Hamilton, Ontario, and is currently recruiting participants.

To be eligible for the trial, participants need to be at least 18 years old and have active pouchitis, which is measured using a specific scoring system. Women who can become pregnant must agree to use birth control during the trial. However, people who are already involved in another clinical trial, cannot give consent, have serious health issues, or have a current infection with Clostridium difficile are not eligible to participate. If you join the study, you will be randomly assigned to receive either the FMT treatment or a placebo, and you will help researchers learn more about how effective this approach can be for managing pouchitis.

Gender

ALL

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. Participating in another clinical trial
• • 2. Unable to give informed consent
• • 3. Severe comorbid medical illness
• • 4. Concomitant Clostridium difficile infection