Fecal Microbiota Transplantation for Ulcerative Colitis

NCT01742754 | Terminated

• 1 other identifier: 41454-K
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (7)

• Engraftment of fecal microbiota transplantation at 7 days.

  7 days

• Durability of Fecal Microbiota Transplantation at 12 weeks

  12 weeks

• Clinical remission at 4 weeks.

  4 weeks

• Clinical remission at 12 weeks.

  12 weeks

• Endoscopic remission at 4 weeks.

  4 weeks

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon.

Other: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation OTHER

Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate UC.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead
• The Broad Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98103, United States

Location

Related Publications (2)

• 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.

  PMID: 23034604 BACKGROUND

• 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.

  PMID: 26288277 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Timothy L Zisman, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Medicine/Division of Gastroenterology

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 5, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)