FMT for Postop Crohn's Disease

Study Overview
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Brief Summary
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People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery. Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.

Official Title
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Fecal Microbiota Transplant for Postoperative Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Biological: Capsule fecal microbiota material (cap-FMT)
* Biological: Colonoscopic fecal microbiota material (colo-FMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to sign informed consent form Age 18 or older English speaking Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence. Prior ileocecal resection for CD Stable medications for 30 days Women of reproductive age: Agree to remain abstinent or use effective birth control Able and willing to comply with all study procedures Exclusion Criteria: Antibiotic therapy within 15 days Probiotic therapy within 15 days Adenomatous polyps that have not been removed Anticipated antibiotic use over the study period Subtotal or total colectomy Current ostomy (ileostomy or colonoscopy) Anticipated surgical procedure over study period Pregnancy Severe food allergy Diagnosis of end stage liver disease or cirrhosis Absolute neutrophil count < 500 cell / uL Life expectancy < 6 months

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsule fecal microbiota material (cap-FMT)<br>Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly. | Biological: Capsule fecal microbiota material (cap-FMT)<br>* Cap-FMT consists of Lyophilized FMT administered at 5 x 10^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10^12 bacteria.<br>|
| Active Comparator: Colonoscopic fecal microbiota material (colo-FMT) plus placebo<br>Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly. | Biological: Colonoscopic fecal microbiota material (colo-FMT)<br>* Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ileal-associated microbiota engraftment | Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Ileocecal resection, Fecal microbiota transplant, Intestinal microbiota transplant