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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078803
• Other study ID #: 66218
• Status: Completed
• Phase: Phase 2
• Start date: March 28, 2017
• Est. completion date: August 29, 2022

Study information

• Verified date: September 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 29, 2022
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Fecal Microbiota Transplant (FMT)
FMT delivered by colonoscopy and oral capsules
• Placebo
Transfer of water only

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	McMaster University, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

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