RecruitingPhase 2

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Canada40 participantsStarted 2022-06-03

Plain-language summary

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 18 years of age or older but less than 75 years of age
✓. Able to provide informed consent
✓. Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
✓. Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge
✓. Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:
✓. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
✓. Willing and able to comply with all required study procedures

Exclusion criteria

✕. Severe UC requiring hospitalization
✕. Indeterminate colitis
✕. Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
✕. Evidence of toxic megacolon or gastrointestinal perforation on imaging
✕. Abdominal surgery within the past 60 days
✕. Pregnant or lactating
✕. Unwilling to discontinue non-dietary probiotic
✕. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study

What they're measuring

Proportion of participants with serious adverse events (SAEs) of interest up to week 8 in each group (ie vedolizumab with or without LFMT, ustekinumab with or without LFMT).

Timeframe: 24 weeks

Trial details

NCT IDNCT05327790

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

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