Skip to content

A multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis patient population

Ulcerative Colitis

This randomized study will compare the effect of fecal transplant or placebo, in persons with ulcerative colitis. Participants will be grouped into either: Adjunct therapy group (add to current therapy) or Co-Administration group (those initiating or switch to a new advanced agent). Participants will take oral pills for up to 24 weeks to see if fecal transplant may be lead to remission faster and/ or prevent patients from having to switch therapies. Participants will be followed up to 24 weeks in duration. Several questionnaires will also be administered. Samples, including blood, stool and colonic biopsies will also be collected so the researchers can better understand which microbes are important.

null

Participation Requirements

  • Sex:

    Female, Male

  • Eligible Ages:

    18 to 80

Participation Criteria

Inclusion Criteria:
-18 years old or older
-Can understand and agree to participate in the study (provide informed consent)
-Diagnosed with ulcerative colitis
-Currently experiencing active ulcerative colitis
-Adjunct therapy group only: participants already on an approved therapy including 5 ASA
-Co-administration group only: participants plan to initiate or switch to a new advanced agent
-Women who can get pregnant must use a reliable birth control method for at least 4 weeks before starting the treatment and throughout the study
-Willing to follow all the study rules and procedures
Exclusion Criteria:
-Severe ulcerative colitis (UC) that needs hospitalization
-Having Crohn’s disease or irritable bowel syndrome (IBS)
-Recent intestinal infection or toxic megacolon
-Planning to have your colon removed (colectomy) or have had recent abdominal surgery
-Very low white blood cell count (less than 0.5) or very high white blood cell count (over 35)
-Taking or planning to take another experimental treatment
-Pregnant or breastfeeding
-Used antibiotics in the last 30 days or will need antibiotics during the study
-Had a fecal microbiota transplant (FMT) in the last 6 months

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Rose Franz

[email protected]
7802481342
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00160199