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

Tracking Information

• First Submitted Date: January 12, 2017
• First Posted Date: March 13, 2017
• Last Update Posted Date: September 7, 2022
• Actual Study Start Date: March 28, 2017
• Actual Primary Completion Date: June 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 7, 2017)

Clinical and Endoscopic Remission [ Time Frame: Week 8 ]

Harvey Bradshaw Index <5 and Simple endoscopic score <5

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 7, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fecal Transplant for Crohn's Disease
• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Crohn Disease

Intervention

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

Study Arms

• Experimental: Fecal microbiota transplant
  Transfer of healthy human gut bacteria
  Intervention: Biological: Fecal Microbiota Transplant (FMT)
• Placebo Comparator: Placebo
  Water
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 1, 2022): 38
• Original Estimated Enrollment (submitted: March 7, 2017): 126
• Actual Study Completion Date: August 29, 2022
• Actual Primary Completion Date: June 21, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03078803
• Other Study ID Numbers: 66218
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Alberta
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current

Collaborators

• University of Calgary
• McMaster University

Investigators

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

• PRS Account: University of Alberta
• Verification Date: September 2022