RecruitingPhase 1

Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

Canada85 participantsStarted 2026-03-01

Plain-language summary

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years of age or older
✓. Able to provide informed consent
✓. Established UC diagnosis through standard endoscopic and histologic criteria
✓. Active UC
✓. 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
✕. Crohn's disease or indeterminate colitis
✕. Irritable bowel syndrome
✕. Intestinal infection within 4 weeks of enrollment
✕. Evidence of toxic megacolon or gastrointestinal perforation on imaging
✕. Planned colectomy
✕. Abdominal surgery within 60 days of enrollment
✕. Neutropenia with absolute neutrophil count \<0.5 x 109/L

What they're measuring

Steroid-free endoscopic remission

Timeframe: At 8 weeks

Trial details

NCT IDNCT07401680

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

Dina Kao, MD,FRCPC

780-233-6025 dkao@ualberta.ca

View on ClinicalTrials.gov More Ulcerative Colitis trials