Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
Key facts
- Where
- Calgary and Edmonton, CanadaSee the 2 sites
- Phase
- Phase 1
Where in Canada
- University Of CalgaryCalgary, CanadaNot yet recruiting
- University of AlbertaEdmonton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alberta
- Trial code
- NCT07401680
- Record updated
- 4 June 2026
- Original description
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.Read full original descriptionShow less
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
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.
Inclusion: 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: Abdominal surgery within 60 days of enrollment; Planned or actively taking another investigational product; Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study; 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; 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; Neutropenia with absolute neutrophil count <0.5 x 109/L; Peripheral white blood cell count > 35.0 x 109/L and fever (>38C); Severe UC requiring hospitalization; Planned colectomy; Pregnancy or breastfeeding; Unwilling to discontinue non-dietary probiotic; FMT for any reason within 6 months of enrollment; Investigator's judgement that enrolment is not in the best interest of the patient.