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Recruiting

Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

NCT07401680 · University of Alberta
In plain English

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Official title
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
About this study
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease. Participants will be grouped into one of two categories 1. Add to current therapy (i.e., adjunct therapy) or 2. Initiate or switch to a new advanced agent (i.e., co-administration) The study will recruit 85 outpatients at 3 Canadian healthcare centres
Eligibility criteria
Inclusion Criteria: 1. 18 years of age or older 2. Able to provide informed consent 3. Established UC diagnosis through standard endoscopic and histologic criteria 4. Active UC 5. 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 6. Willing and able to comply with all required study procedures Exclusion Criteria: 1. Severe UC requiring hospitalization 2. Crohn's disease or indeterminate colitis 3. Irritable bowel syndrome 4. Intestinal infection within 4 weeks of enrollment 5. Evidence of toxic megacolon or gastrointestinal perforation on imaging 6. Planned colectomy 7. Abdominal surgery within 60 days of enrollment 8. Neutropenia with absolute neutrophil count \<0.5 x 109/L 9. Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C) 10. Planned or actively taking another investigational product 11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse 12. Severe underlying disease such that the patient is not expected to survive for at least 30 days 13. Pregnancy or breastfeeding 14. Unwilling to discontinue non-dietary probiotic 15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study 16. FMT for any reason within 6 months of enrollment 17. Investigator's judgement that enrolment is not in the best interest of the patient
Study design
Enrollment target: 85 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-03-01
Estimated completion: 2028-12-01
Last updated: 2026-06-04
Interventions
Other: Lyophilized Fecal Microbiota Transplantation (LFMT)Other: Placebo
Primary outcomes
  • Steroid-free endoscopic remission (At 8 weeks)
Sponsor
University of Alberta · other
With: University of Calgary
Contacts & investigators
ContactDina Kao, MD,FRCPC · contact · dkao@ualberta.ca · 780-492-5257
All locations (2)
University of CalgaryNot Yet Recruiting
Calgary, Alberta, Canada
University of AlbertaRecruiting
Edmonton, Alberta, Canada
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population · TrialPath