Fecal Transplant for Crohn's Disease

NCT ID: NCT03078803

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2022-08-29

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fecal microbiota transplant

Transfer of healthy human gut bacteria

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type: BIOLOGICAL

FMT delivered by colonoscopy and oral capsules

Placebo

Water

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Transfer of water only

Interventions

Fecal Microbiota Transplant (FMT)

FMT delivered by colonoscopy and oral capsules

Intervention Type: BIOLOGICAL

Placebo

Transfer of water only

Intervention Type: BIOLOGICAL

Other Intervention Names

FMT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dina Kao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Foothills Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

Kao D, Wong K, Jijon H, Moayyedi P, Franz R, McDougall C, Hotte N, Panaccione R, Semlacher E, Kroeker KI, Peerani F, MacDonald KV, Xu H, Narula N, Turbide C, Marshall DA, Madsen KL. Preliminary Results From a Multicenter, Randomized Trial Using Fecal Microbiota Transplantation to Induce Remission in Patients With Mild-to-Moderate Crohn's Disease. Am J Gastroenterol. 2024 Nov 12;120(6):1334-1344. doi: 10.14309/ajg.0000000000003196.

Reference Type: DERIVED

PMID: 39530534 (View on PubMed)

Other Identifiers

66218

Identifier Type: -

Identifier Source: org_study_id