Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

December 13, 2016 updated by: Dina Kao, University of Alberta

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

same as above

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 and < 65 years
  2. Diagnosis of UC for > 3 months but < 5 years prior to screening as determined by the investigators
  3. Those with mild to moderate UC
  4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) for > 3 months

  5. Where applicable, those who are taking the following medications must be at a stable dose defined as:

    i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine or 6-MP must be at a stable dose for > 8 weeks

  6. ability to provide informed consent
  7. evidence of active inflammation

Exclusion Criteria:

  1. Those whose disease is limited to the rectum (ie. proctitis)
  2. Those with colectomy or diverting ileostomy
  3. Those who are pregnancy or plan to be pregnant during the trial
  4. Those who are breastfeeding or plan to breast feed during the trial
  5. Those who are on or have previously failed a biological agent
  6. Those with an active infection requiring antibiotic therapy
  7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
  8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
  9. Those with allergy to ciprofloxacin and metronidazole
  10. Those with colonic mucosal dysplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplantation
serial Fecal Microbiota Transplantation
Biological: Fecal Microbiota Transplant
serial FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mayo score reduction
Time Frame: 12 and 32 weeks
Patients with at least 3 point reduction in partial Mayo scoring index at week 12 and at week 32 in the extension phase.
12 and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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