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Fecal Microbiota Transplantation for Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal Microbiota Transplantation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Engraftment of fecal microbiota transplantation at 7 days.
As in primary aim but at 7 days.
Durability of Fecal Microbiota Transplantation at 12 weeks
As in primary aim but at 12 weeks.
Clinical remission at 4 weeks.
Defined as Mayo score <=2 with no subscore >1
Clinical remission at 12 weeks.
Defined as Mayo score <=2 with no subscore >1
Endoscopic remission at 4 weeks.
Mayo endoscopy scope of 0.
Number of patients with worsened disease.
Increase in Mayo score of >2.
Number of adverse events.

Full Information

First Posted
November 29, 2012
Last Updated
November 11, 2013
Sponsor
University of Washington
Collaborators
The Broad Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01742754
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
IND required by the FDA for all future FMTs.
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
The Broad Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal Microbiota Transplantation
Arm Type
Experimental
Arm Description
Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.
Primary Outcome Measure Information:
Title
Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Engraftment of fecal microbiota transplantation at 7 days.
Description
As in primary aim but at 7 days.
Time Frame
7 days
Title
Durability of Fecal Microbiota Transplantation at 12 weeks
Description
As in primary aim but at 12 weeks.
Time Frame
12 weeks
Title
Clinical remission at 4 weeks.
Description
Defined as Mayo score <=2 with no subscore >1
Time Frame
4 weeks
Title
Clinical remission at 12 weeks.
Description
Defined as Mayo score <=2 with no subscore >1
Time Frame
12 weeks
Title
Endoscopic remission at 4 weeks.
Description
Mayo endoscopy scope of 0.
Time Frame
4 weeks
Title
Number of patients with worsened disease.
Description
Increase in Mayo score of >2.
Time Frame
4 weeks.
Title
Number of adverse events.
Time Frame
12 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy L Zisman, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23034604
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.
Results Reference
background
PubMed Identifier
26288277
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.
Results Reference
derived

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Fecal Microbiota Transplantation for Ulcerative Colitis

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