A Phase 2 interventional study of Fecal Microbiota Transplant (FMT) and Placebo in Crohn Disease, sponsored by University of Alberta. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by University of Alberta · Phase 2, Interventional, and Treatment
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
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.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 38 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Alberta is the lead sponsor of 819 studies on the registry; 168 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Transfer of healthy human gut bacteria
Biological: Fecal Microbiota Transplant (FMT)
Water
Biological: Placebo
FMT delivered by colonoscopy and oral capsules
Also known as: FMT
Transfer of water only
Clinical and Endoscopic Remission
Harvey Bradshaw Index \<5 and Simple endoscopic score \<5
Time frame: Week 8
Clinical response
Harvey Bradshaw Index reduction by 3 points
Time frame: Week 8
Clinical remission
Harvey Bradshaw Index \<5
Time frame: Week 8
Endoscopic response
Simple endoscopic score reduction by 50%
Time frame: Week 8
Endoscopic remission
Simple endoscopic score \<5
Time frame: Week 8
Quality of Life 1
Mean changes in Short Inflammatory Bowel Disease Questionnaire
Time frame: Week 8
Quality of Life 2
Mean changes in Euro five dimensions questionnaire
Time frame: Week 8
Quality of Life 3
Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire
Time frame: Week 8
Plan to share: No
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fecal microbiota