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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.
University of Washington
Seattle, Washington, United States
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.
Time frame: 4 weeks
Engraftment of fecal microbiota transplantation at 7 days.
As in primary aim but at 7 days.
Time frame: 7 days
Durability of Fecal Microbiota Transplantation at 12 weeks
As in primary aim but at 12 weeks.
Time frame: 12 weeks
Clinical remission at 4 weeks.
Defined as Mayo score \<=2 with no subscore \>1
Time frame: 4 weeks
Clinical remission at 12 weeks.
Defined as Mayo score \<=2 with no subscore \>1
Time frame: 12 weeks
Endoscopic remission at 4 weeks.
Mayo endoscopy scope of 0.
Time frame: 4 weeks
Number of patients with worsened disease.
Increase in Mayo score of \>2.
Time frame: 4 weeks.
Number of adverse events.
Time frame: 12 weeks.
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