Fecal Microbiota Transplantation for Ulcerative Colitis
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About
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.
Enrollment
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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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
7 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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