NCT03078803

Fecal Transplant for Crohn's Disease

A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease

Detailed description

Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated. Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks. Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected. Colonoscopies recorded and reviewed by a central reader.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant (FMT)	FMT delivered by colonoscopy and oral capsules
BIOLOGICAL	Placebo	Transfer of water only

Timeline

• Start date: 2017-03-28
• Primary completion: 2021-06-21
• Completion: 2022-08-29
• First posted: 2017-03-13
• Last updated: 2022-09-07

Locations

3 sites across 1 country: Canada