Fecal Transplant for Crohn's Disease

Crohn Disease Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT03078803
• Study type: Interventional
• Source: University of Alberta
• Status: Completed
• Phase: Phase 2
• Start date: March 28, 2017
• Completion date: August 29, 2022