A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Dina Kao, MD,FRCPC
dkao@ualberta.ca
780-492-5257
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 85
Treatments
Experimental: Adjunct therapy group (LFMT)
Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks~Maintenance phase: 1 capsule daily x 16 weeks
Placebo_comparator: Adjunct therapy group (Placebo)
The placebo capsules will appear identical to LFMT capsules and same dosing will apply.
Experimental: Co-Administration therapy group (LFMT)
Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks~Maintenance phase: 1 capsule daily x 16 weeks
Placebo_comparator: Co-Administration therapy group (Plcebo)
The placebo capsules will appear identical to LFMT capsules and same dosing will apply.
Related Therapeutic Areas
Sponsors
Collaborators: University of Calgary
Leads: University of Alberta