Status:
RECRUITING
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
Lead Sponsor:
University of Alberta
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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. Patients must be:
- 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
Exclusion
- 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 109/L
- Peripheral white blood cell count \> 35.0 x 109/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 the following medications:
- rectal/topical therapy within 2 weeks of screening
- cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
- tofacitinib within 4 weeks of screening
- adalimumab or infliximab within 8 weeks of screening
- vedolizumab within 8 weeks of screening
- ustekinumab within 12 weeks of screening
- prednisone \> 30 mg/d
- Investigator deems enrolment in the study is not in the best interest of the patient
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05327790
Start Date
June 3 2022
End Date
March 31 2026
Last Update
July 4 2025
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8