Clinical trial NCT03078803: Fecal Transplant for Crohn's Disease
Official title: A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: fecal transplant
inflammatory bowel disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: McMaster University
First posted: 2017-03-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical and Endoscopic Remission
timeFrame: Week 8
Secondary outcomes:
measure: Clinical response
timeFrame: Week 8
measure: Clinical remission
timeFrame: Week 8
measure: Endoscopic response
timeFrame: Week 8
measure: Endoscopic remission
timeFrame: Week 8
measure: Quality of Life 1
timeFrame: Week 8
measure: Quality of Life 2
timeFrame: Week 8
measure: Quality of Life 3
timeFrame: Week 8
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: University of Alberta
name: Dina Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: