Clinical trial NCT01742754: Fecal Microbiota Transplantation for Ulcerative Colitis
Official title: Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The Broad Foundation
First posted: 2012-12-05
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.
timeFrame: 4 weeks
Secondary outcomes:
measure: Engraftment of fecal microbiota transplantation at 7 days.
timeFrame: 7 days
measure: Durability of Fecal Microbiota Transplantation at 12 weeks
timeFrame: 12 weeks
measure: Clinical remission at 4 weeks.
timeFrame: 4 weeks
measure: Clinical remission at 12 weeks.
timeFrame: 12 weeks
measure: Endoscopic remission at 4 weeks.
timeFrame: 4 weeks
measure: Number of patients with worsened disease.
timeFrame: 4 weeks.
measure: Number of adverse events.
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Timothy L Zisman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93.
citation: Damman CJ, Brittnacher MJ, Westerhoff M, Hayden HS, Radey M, Hager KR, Marquis SR, Miller SI, Zisman TL. Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. PLoS One. 2015 Aug 19;10(8):e0133925. doi: 10.1371/journal.pone.0133925. eCollection 2015.