NCT07401680

Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases
• Clostridioides Difficile Infection

Interventions

Type	Name	Description
OTHER	Lyophilized Fecal Microbiota Transplantation (LFMT)	LFMT by oral capsules
OTHER	Placebo	Placebo capsules does not contain FMT

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

2 sites across 1 country: Canada