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Fecal Microbiota Transplantation for Ulcerative Colitis

NCT ID: NCT01742754

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fecal Microbiota Transplantation

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

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type OTHER

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

Interventions

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Fecal Microbiota Transplantation

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Broad Foundation

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Timothy Zisman

Assistant Professor of Medicine, Medicine/Division of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy L Zisman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23034604 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26288277 (View on PubMed)

Other Identifiers

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41454-K

Identifier Type: -

Identifier Source: org_study_id