Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment. The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by transplanting fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.

Official Title
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Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Conditions
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Ulcerative Colitis, Active Moderate

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18-75 years of age. Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response). Patients may be on any class of IBD-related medication (excluding steroids) Patients must be on stable medication regimen for at least 6 weeks prior to enrollment. Ability to understand and willingness to sign informed consent document Exclusion Criteria: Patient who are asymptomatic Patients with severe, refractory disease (defined as Mayo scores of > 10, or endoscopic disease activity score of > 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol Prior colectomy Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture. Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment Systemic antibiotic use within prior 6 weeks to enrollment Regular probiotic supplement use within prior 48 hours to enrollment Pregnancy or breastfeeding Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy) History of anaphylaxis (severe allergic reaction) Documented allergy to fluoroquinolones, metronidazole Life expectancy less than 12 months Age less than 18 or greater than 75 years of age History of esophageal or gastric motility disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Sham FMT and Sham Microbial Maintenance plus standard therapy | Biological: Placebo<br> <br> |
| Experimental: Treatment<br>FMT and microbial maintenance plus standard therapy | Biological: Fecal Microbiota Transplant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asses Endoscopic Stages of the Colon Pre/Post FMT | Assess endoscopic stage of the inflamed colon (endoscopic Mayo score) and assess the histologic stage of the biopsied colon (quiescent/mild/moderate/severe) pre and post FMT. | 2 years | 
| Asses Biologic Inflammatory Markers | Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT. | 2 years | 
| Review and Track Patient reported Outcomes via Validated Questionnaires | Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36) | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metagenomic sequencing in Stool samples after FMT treatment | Trace the effect FMT therapy has on microbiome diversity and to track whether this effect is sustained during and after therapy via metagenomic sequencing of stool samples at time 0, and weeks 6, 12, and 18. | After 6, 12, and 18 Weeks |