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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
FMT delivered by colonoscopy and oral capsules
Transfer of water only
Foothills Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
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
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