Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05327790

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Led by University of Alberta · Updated on 2026-05-06

40

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older but less than 75 years of age
  • Able to provide informed consent
  • Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
  • Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score >1 with disease that extends 15 cm or more from the anal verge
  • Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab
  • Biologic naive or have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules
  • 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
Not Eligible

You will not qualify if you...

  • Severe UC requiring hospitalization
  • Indeterminate colitis
  • Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
  • Evidence of toxic megacolon or gastrointestinal perforation on imaging
  • Abdominal surgery within the past 60 days
  • Neutropenia with absolute neutrophil count <0.5 x 10^9/L
  • Peripheral white blood cell count > 35.0 x 10^9/L and fever (>38 degrees Celsius)
  • Planned or actively taking another investigational product
  • Uncontrolled medical conditions such as psychiatric disorders or substance abuse
  • Severe underlying disease such that the patient is not expected to survive for at least 30 days
  • Pregnant or lactating
  • Unwilling to discontinue non-dietary probiotic
  • Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
  • FMT within 3 months prior to enrollment
  • Use of rectal/topical therapy within 2 weeks of screening
  • Use of cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
  • Use of tofacitinib within 4 weeks of screening
  • Use of adalimumab or infliximab within 8 weeks of screening
  • Use of vedolizumab within 8 weeks of screening
  • Use of ustekinumab within 12 weeks of screening
  • Use of prednisone > 30 mg/day
  • Investigator deems enrolment in the study is not in the best interest of the patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2X8

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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LFMT vs Placebo in New Biologic Start for Ulcerative Colitis | DecenTrialz