Fecal Transplant for Crohn's Disease

• ClinicalTrials.gov Identifier: NCT03078803
• Recruitment Status: Completed
• First Posted: March 13, 2017
• Last Update Posted: September 7, 2022
• Sponsor: University of Alberta
• Collaborators: University of Calgary; McMaster University
• Information provided by (Responsible Party): University of Alberta

Study Description

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

Condition or disease	Intervention/treatment	Phase
Crohn Disease	Biological: Fecal Microbiota Transplant (FMT); Biological: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 28, 2017
• Actual Primary Completion Date: June 21, 2021
• Actual Study Completion Date: August 29, 2022

Arms and Interventions

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 Name: FMT
Placebo Comparator: Placebo; Water	Biological: Placebo; Transfer of water only

Outcome Measures

Primary Outcome Measures :

1. Clinical and Endoscopic Remission [ Time Frame: Week 8 ]
   Harvey Bradshaw Index <5 and Simple endoscopic score <5

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Canada, Alberta

Foothills Hospital

Calgary, Alberta, Canada, T2N2T9

University of Alberta

Edmonton, Alberta, Canada, T6G 2X8

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada

Sponsors and Collaborators

University of Alberta

University of Calgary

McMaster University

Investigators

• Principal Investigator: Dina Kao, MD; University of Alberta

More Information

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT03078803
• Other Study ID Numbers: 66218
• First Posted: March 13, 2017
• Last Update Posted: September 7, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:

fecal transplant; inflammatory bowel disease

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases