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

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

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Fecal Microbiota Transplant (FMT); Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Foothills Hospital
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• mild to moderate ileal, ileo-colonic or colonic Crohns disease
• active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
• If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
• Use of effective contraception

Exclusion Criteria:

• Antibiotic exposure within 30 days and probiotic exposure within 14 days
• topical inflammatory bowel disease therapy within 2 weeks
• active perianal disease
• requirement for concurrent antibiotic therapy
• SES-CD score <5
• severe CD HBI >25 or need for hospitalization
• abdominal abscess
• extensive colonic resection, subtotal or total colectomy
• ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
• evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
• requiring or expected to require surgical intervention
• history or evidence of adenomatous colonic polyps not removed
• history of evidence of colonic dysplasia
• active substance abuse or psychiatric problems that may interfere with study
• chronic Hep B, C, or HIV infection
• pregnancy or planning to become pregnant
• upper CD
• history of adhesions preventing colonoscopy to cecum
• planned bowel resection within 3 mon of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal microbiota transplant; Transfer of healthy human gut bacteria	Biological: Fecal Microbiota Transplant (FMT); FMT delivered by colonoscopy and oral capsules; Other Names: FMT
Placebo Comparator: Placebo; Water	Biological: Placebo; Transfer of water only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and Endoscopic Remission	Harvey Bradshaw Index <5 and Simple endoscopic score <5	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Harvey Bradshaw Index reduction by 3 points	Week 8
Clinical remission	Harvey Bradshaw Index <5	Week 8
Endoscopic response	Simple endoscopic score reduction by 50%	Week 8
Endoscopic remission	Simple endoscopic score <5	Week 8
Quality of Life 1	Mean changes in Short Inflammatory Bowel Disease Questionnaire	Week 8
Quality of Life 2	Mean changes in Euro five dimensions questionnaire	Week 8
Quality of Life 3	Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire	Week 8

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: McMaster University; University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: inflammatory bowel disease; fecal transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 66218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No