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OpenTrials
Completed

NCT Number: NCT02227342

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.

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Key information

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

same as above

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

  • ability to provide informed consent
  • evidence of active inflammation

Exclusion criteria

  • Those whose disease is limited to the rectum (ie. proctitis)
  • Those with colectomy or diverting ileostomy
  • 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 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
  • Those with colonic mucosal dysplasia

Treatment and study plan

Fecal Microbiota Transplant

Biological

serial FMT

Primary outcomes

  1. 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.

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 Ulcerative Colitis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 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.

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