Fecal Transplant for Crohn's Disease

Phase 2

Completed

• Conditions: Crohn Disease
• Interventions: Biological: Placebo; Biological: Fecal Microbiota Transplant (FMT)

• Registration Number: NCT03078803
• Lead Sponsor: University of Alberta

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-03-28
• Primary Completion: 2021-06-21
• Study Completion: 2022-08-29
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Water
Fecal microbiota transplant	Fecal Microbiota Transplant (FMT)	Transfer of healthy human gut bacteria

Primary Outcome Measures

Name	Time	Method
Clinical and Endoscopic Remission	Week 8	Harvey Bradshaw Index \<5 and Simple endoscopic score \<5

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada