FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Study Overview
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Brief Summary
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Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.

Detailed Description
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Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1 mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical cost for previous treatment is collected as well at pt perspective and QoL.

Official Title
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A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)

Conditions
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Enterocolitis Clostridium Difficile Recurrent

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and < 90 years at the time of Screening. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other. CDI infection under symptomatic control with < 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure. Those with ability to provide informed consent. Exclusion Criteria: Those with complicated CDI, defined as white blood cell>35 or <0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure < 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delivery via capsule<br>Fecal microbiota transplant is delivered by oral capsules | Biological: Fecal Microbiota Transplant<br>* transfer of healthy human gut bacteria to restore the microbiome<br>|
| Experimental: Delivery via colonoscopy<br>Fecal microbiota transplant delivered by colonoscopy | Biological: Fecal Microbiota Transplant<br>* transfer of healthy human gut bacteria to restore the microbiome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without recurrent CDI |  | 12 weeks after treatment |