RecruitingPhase 2NCT05327790

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)


Sponsor

University of Alberta

Enrollment

40 participants

Start Date

Jun 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a stool transplant (fecal microbiota transplant, or FMT) given alongside a newly started biologic medication can improve outcomes for patients with active ulcerative colitis. **You may be eligible if...** - You are 18–74 years old - You have a confirmed diagnosis of active ulcerative colitis - Your disease extends at least 15 cm from the anal verge and has a total Mayo score of 6–12 - Your doctor has selected vedolizumab or ustekinumab as your new biologic treatment - You have not used other biologics, OR have not responded to prior biologics **You may NOT be eligible if...** - You are severely ill and require hospitalization - You have had recent abdominal surgery or a C. difficile infection in the past 4 weeks - You are pregnant or breastfeeding - You have recently used antibiotics or certain immunosuppressive medications - You have received FMT in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLyophilized fecal microbiota (LFMT)

vedolizumab or ustekinumab + FMT vs placebo

OTHERPlacebo

Placebo


Locations(1)

University of Alberta Hospital

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05327790


Related Trials