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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03078803
Other study ID # 66218
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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