Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis, Inflammatory Bowel Diseases, Clostridioides Difficile Infection

In brief

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.

Key facts

Study ID

NCT07401680

Run by

University of Alberta

People needed

85

Starts

2026-03-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Peripheral white blood cell count > 35.0 x 109/L and fever (>38C)
• Planned or actively taking another investigational product
• Uncontrolled medical conditions such as psychiatric disorders or substance abuse
• Severe underlying disease such that the patient is not expected to survive for at least 30 days
• Pregnancy or breastfeeding
• Unwilling to discontinue non-dietary probiotic
• Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
• FMT for any reason within 6 months of enrollment
• Investigator's judgement that enrolment is not in the best interest of the patient

Where it is running

• University of Alberta — Edmonton, Alberta, Canada (enrolling)
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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