Fecal Transplant for Crohn's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant (FMT)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbiota transplant<br>Transfer of healthy human gut bacteria | Biological: Fecal Microbiota Transplant (FMT)<br>* FMT delivered by colonoscopy and oral capsules<br>* Other names: FMT;|
| Placebo Comparator: Placebo<br>Water | Biological: Placebo<br>* Transfer of water only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and Endoscopic Remission | Harvey Bradshaw Index <5 and Simple endoscopic score <5 | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Harvey Bradshaw Index reduction by 3 points | Week 8 | 
| Clinical remission | Harvey Bradshaw Index <5 | Week 8 | 
| Endoscopic response | Simple endoscopic score reduction by 50% | Week 8 | 
| Endoscopic remission | Simple endoscopic score <5 | Week 8 | 
| Quality of Life 1 | Mean changes in Short Inflammatory Bowel Disease Questionnaire | Week 8 | 
| Quality of Life 2 | Mean changes in Euro five dimensions questionnaire | Week 8 | 
| Quality of Life 3 | Mean changes in Work Productivity and Activity Impairment: Crohns Disease questionnaire | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal transplant, inflammatory bowel disease