NCT05327790

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

A Dual-center, Double Blind, Randomized Placebo-controlled Pilot Trial of Concomitant Lyophilized Fecal Microbiota Transplantation (LFMT) and Biologic Therapy (Vedolizumab or Ustekinumab) for the Induction of Remission in Ulcerative Colitis (UC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.

Detailed description

This is dual-center, randomized, double-blind, placebo-controlled pilot trial for UC patients with active disease who are being initiated on treatment with vedolizumab or ustekinumab. The study will recruit 40 outpatients at 2 Canadian healthcare centres at the University of Alberta Hospital (University of Alberta), and the University of Manitoba.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Lyophilized fecal microbiota (LFMT)	vedolizumab or ustekinumab + FMT vs placebo
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-06-03
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-04-14
• Last updated: 2026-01-30

Locations

1 site across 1 country: Canada