Fecal Microbiota Transplantation for Ulcerative Colitis

Study Overview
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Brief Summary
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Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.

Official Title
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Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate UC. Exclusion Criteria: Antibiotic exposure in the last 3 months. Biologic or immunomodulatory therapy within the last 3 months. Corticosteroid therapy or probiotics within the last 2 weeks. Severely active disease (defined as Mayo scores of 10 or greater, or patients with endoscopic disease activity scores of 3 or greater).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation<br>Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon. | Other: Fecal Microbiota Transplantation<br>* Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation. | Metagenomic shotgun sequencing using Iluminia technology will be used to evaluate for engraftment. Metagenomic data will be analyzed using CompareReads. A % similarity to the recipient > than % similarity to the donor will be defined as engraftment. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment of fecal microbiota transplantation at 7 days. | As in primary aim but at 7 days. | 7 days | 
| Durability of Fecal Microbiota Transplantation at 12 weeks | As in primary aim but at 12 weeks. | 12 weeks | 
| Clinical remission at 4 weeks. | Defined as Mayo score <=2 with no subscore >1 | 4 weeks | 
| Clinical remission at 12 weeks. | Defined as Mayo score <=2 with no subscore >1 | 12 weeks | 
| Endoscopic remission at 4 weeks. | Mayo endoscopy scope of 0. | 4 weeks | 
| Number of patients with worsened disease. | Increase in Mayo score of >2. | 4 weeks. | 
| Number of adverse events. |  | 12 weeks. |