Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD 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 CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alberta Hospital

Edmonton, Alberta, Canada

About this study

Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 and < 65 years at the time of screening
Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
Those with mild to moderate CD
Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for > 3 months
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, 6-MP, and methotrexate must be at a stable dose for > 8 weeks

ability to provide informed consent
evidence of active colonic inflammation

Exclusion criteria

Those with prior ileo-cecal resection
Those who are pregnancy or plan to be pregnant during the trial
Those who are breastfeeding or plan to breast feed during the trial
Those who are on or have previously failed a biological agent
Those who have active perianal disease as determined by investigators
Those with an active infection requiring antibiotic therapy
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
Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
Those with allergy to ciprofloxacin and metronidazole

Treatment and study plan

Fecal Microbiota Transplant

Biological

Fecal transplant processed from routinely screened universal donor

Primary outcomes

HBI score reduction

Time frame: 12 and 32 weeks

Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 24, 2014
Registry last updated: Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed