LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

NCT05327790 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Lyophilized fecal microbiota (LFMT)

vedolizumab or ustekinumab + FMT vs placebo

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327790 on ClinicalTrials.gov