Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis (FMTUC)
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.
|Ulcerative Colitis, Active Moderate||Biological: Fecal Microbiota Transplant Biological: Placebo||Early Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis|
- Asses Endoscopic Stages of the Colon Pre/Post FMT [ Time Frame: 2 years ]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.
- Asses Biologic Inflammatory Markers [ Time Frame: 2 years ]Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.
- Review and Track Patient reported Outcomes via Validated Questionnaires [ Time Frame: 2 Years ]Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)
- Change in metagenomic sequencing in Stool samples after FMT treatment [ Time Frame: After 6, 12, and 18 Weeks ]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.
- Asses changes in T-cell measures and serotonin signaling in mucosal biopsy samples and peripheral blood samples [ Time Frame: 2 years ]Explore potential therapeutic mechanisms of FMT therapy. Changes in the host immune response before and after treatment will be assessed via measurement of both mucosal and peripheral T-cells populations (Th1, Th2, Th17) using mucosal biopsies and blood samples respectively.Changes in mucosal serotonin signaling will be measured using mucosal biopsies.
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Sham Comparator: Control
Sham FMT and Sham Microbial Maintenance plus standard therapy
FMT and microbial maintenance plus standard therapy
|Biological: Fecal Microbiota Transplant|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02390726
|United States, Vermont|
|The University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Peter L Moses, MD||The University of Vermont Medical Center|