RecruitingPhase 2NCT03545386

Fecal Microbiota Transplantation for Pouchitis

Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis


Sponsor

McMaster University

Enrollment

34 participants

Start Date

Apr 17, 2019

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

Pouchitis is inflammation of the internal pouch created in patients who have had surgery to remove their colon (often due to ulcerative colitis or familial polyposis). It causes diarrhea, urgency, and abdominal pain, and can significantly affect quality of life. This study tests fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor — as a treatment for active pouchitis. The idea is that restoring a healthy balance of gut microbes may calm the inflammation driving pouchitis. FMT has shown promise in recurrent Clostridioides difficile infection and researchers believe it may work in pouchitis by rebalancing the disrupted microbiome of the pouch. You may be eligible if: - You are 18 years old or older - You have a confirmed internal pouch - You have active pouchitis with a PDAI score between 7 and 18 - You are willing to use contraception if you are a woman of childbearing potential You may NOT be eligible if: - You are already participating in another clinical trial - You cannot provide informed consent - You have a severe medical illness - You have an active Clostridioides difficile (C. diff) infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFecal microbiota transplantation

Stool from healthy donor administered via enema

OTHERPlacebos

Saline with food coloring administered via enema


Locations(1)

McMaster University

Hamilton, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03545386


Related Trials