Crohn Disease
Conditions
Keywords
fecal transplant, inflammatory bowel 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.
Interventions
BIOLOGICALFecal Microbiota Transplant (FMT)
FMT delivered by colonoscopy and oral capsules
BIOLOGICALPlacebo
Transfer of water only
Sponsors
University of Calgary
McMaster University
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Endoscopic Remission | Week 8 | Harvey Bradshaw Index \<5 and Simple endoscopic score \<5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | Week 8 | Harvey Bradshaw Index \<5 |
| Endoscopic response | Week 8 | Simple endoscopic score reduction by 50% |
| Endoscopic remission | Week 8 | Simple endoscopic score \<5 |
| Clinical response | Week 8 | Harvey Bradshaw Index reduction by 3 points |
| Quality of Life 2 | Week 8 | Mean changes in Euro five dimensions questionnaire |
| Quality of Life 3 | Week 8 | Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire |
| Quality of Life 1 | Week 8 | Mean changes in Short Inflammatory Bowel Disease Questionnaire |
Countries
Canada
Outcome results
None listed