Fecal Microbiota Transplantation for Ulcerative Colitis

This study has been terminated.
(IND required by the FDA for all future FMTs.)
Sponsor:
Collaborator:
The Broad Foundation
Information provided by (Responsible Party):
Timothy Zisman, University of Washington
ClinicalTrials.gov Identifier:
NCT01742754
First received: November 29, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Other: Fecal Microbiota Transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Engraftment of fecal microbiota transplantation at 7 days. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    As in primary aim but at 7 days.

  • Durability of Fecal Microbiota Transplantation at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As in primary aim but at 12 weeks.

  • Clinical remission at 4 weeks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Defined as Mayo score <=2 with no subscore >1

  • Clinical remission at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Defined as Mayo score <=2 with no subscore >1

  • Endoscopic remission at 4 weeks. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Mayo endoscopy scope of 0.

  • Number of patients with worsened disease. [ Time Frame: 4 weeks. ] [ Designated as safety issue: Yes ]
    Increase in Mayo score of >2.

  • Number of adverse events. [ Time Frame: 12 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: October 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon.
Other: Fecal Microbiota Transplantation
Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742754

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98103
Sponsors and Collaborators
University of Washington
The Broad Foundation
Investigators
Principal Investigator: Timothy L Zisman, MD University of Washington
  More Information

Publications:
Responsible Party: Timothy Zisman, Assistant Professor of Medicine, Medicine/Division of Gastroenterology, University of Washington
ClinicalTrials.gov Identifier: NCT01742754     History of Changes
Other Study ID Numbers: 41454-K
Study First Received: November 29, 2012
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014