NCT04202211

FMT for Remission of Active Ulcerative Colitis in Adults

A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
BIOLOGICAL	FMT oral	lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
BIOLOGICAL	FMT enema	lyophilized FMT given via enema (1) twice weekly for total of 8 weeks
OTHER	Placebo oral	placebo given orally (10 capsules) twice weekly for total of 8 weeks
OTHER	Placebo enema	placebo given via enema (1) twice weekly for total of 8 weeks

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-01
• Completion: 2028-12-01
• First posted: 2019-12-17
• Last updated: 2023-05-10

Locations

3 sites across 1 country: Canada