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A comparison between fecal transplant and placebo in ulcerative colitis patients who are about to start Entyvio or Stelara

Ulcerative Colitis

In this randomized study comparing either fecal transplant or placebo, ulcerative colitis (UC) patients who are about to start either Entyvio or Stelara will receive treatments by oral pills for 8 weeks to see if fecal transplant may be lead to remission faster without any safety concern. 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 study the effects of fecal transplant on patients to better understand how microbiome plays a role. This is the first study which combines a biologic with fecal transplant in UC.

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Participation Requirements

  • Sex:

    Female, Male
  • Eligible Ages:

    18 to 75

Participation Criteria

Inclusion Criteria:
Patients who have ulcerative colitis about to start either vedolizumab (Entyvio) or ustekinumab (Stelara)
Exclusion Criteria:
Patients whose ulcerative colitis is severe requiring hospitalization or surgery.
Patients of child bearing age and do not want to use some form of contraception.

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00117170