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Fecal Microbiota Transplantation for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742754
Recruitment Status : Terminated (IND required by the FDA for all future FMTs.)
First Posted : December 5, 2012
Last Update Posted : November 13, 2013
The Broad Foundation
Information provided by (Responsible Party):
Timothy Zisman, University of Washington

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Fecal Microbiota Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation. [ Time Frame: 4 weeks ]
    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 :
  1. Engraftment of fecal microbiota transplantation at 7 days. [ Time Frame: 7 days ]
    As in primary aim but at 7 days.

  2. Durability of Fecal Microbiota Transplantation at 12 weeks [ Time Frame: 12 weeks ]
    As in primary aim but at 12 weeks.

  3. Clinical remission at 4 weeks. [ Time Frame: 4 weeks ]
    Defined as Mayo score <=2 with no subscore >1

  4. Clinical remission at 12 weeks. [ Time Frame: 12 weeks ]
    Defined as Mayo score <=2 with no subscore >1

  5. Endoscopic remission at 4 weeks. [ Time Frame: 4 weeks ]
    Mayo endoscopy scope of 0.

  6. Number of patients with worsened disease. [ Time Frame: 4 weeks. ]
    Increase in Mayo score of >2.

  7. Number of adverse events. [ Time Frame: 12 weeks. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742754

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United States, Washington
University of Washington
Seattle, Washington, United States, 98103
Sponsors and Collaborators
University of Washington
The Broad Foundation
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Principal Investigator: Timothy L Zisman, MD University of Washington
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Timothy Zisman, Assistant Professor of Medicine, Medicine/Division of Gastroenterology, University of Washington Identifier: NCT01742754    
Other Study ID Numbers: 41454-K
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases