LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Last updated: June 4, 2024
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcerative Colitis

Ulcers

Bowel Dysfunction

Treatment

Lyophilized fecal microbiota (LFMT)

Placebo

Clinical Study ID

NCT05327790
Pro00117170
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older but less than 75 years of age

  2. Able to provide informed consent

  3. Established ulcerative colitis diagnosis determined by a physician through standardendoscopic and histologic criteria

  4. Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score >1with disease that extends 15 cm or more from the anal verge

  5. Selected by treating physician for initiation of biologic treatment with eithervedolizumab or ustekinumab. Patients must be:

  • Biologic naive; OR

  • Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules

  1. Use of effective contraception method for women of childbearing potential for atleast 4 weeks prior to receiving study treatment and for the duration of the trial

  2. Willing and able to comply with all required study procedures

Exclusion

Exclusion Criteria:

  1. Severe UC requiring hospitalization

  2. Indeterminate colitis

  3. Evidence of or treatment for C difficile infection or other intestinal pathogen,including CMV, within 4 weeks prior to enrollment

  4. Evidence of toxic megacolon or gastrointestinal perforation on imaging

  5. 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 degreesCelsius)

  • Planned or actively taking another investigational product

  • Uncontrolled medical conditions such as psychiatric disorders or substanceabuse

  • Severe underlying disease such that the patient is not expected to survive forat least 30 days

  1. Pregnant or lactating

  2. Unwilling to discontinue non-dietary probiotic

  3. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic useduring study

  4. FMT within 3 months prior to enrollment

  5. Use of the following medications:

  6. rectal/topical therapy within 2 weeks of screening

  7. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening

  8. tofacitinib within 4 weeks of screening

  9. adalimumab or infliximab within 8 weeks of screening

  10. vedolizumab within 8 weeks of screening

  11. ustekinumab within 12 weeks of screening

  12. prednisone > 30 mg/d

  13. Investigator deems enrolment in the study is not in the best interest of the patient

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Lyophilized fecal microbiota (LFMT)
Phase: 2
Study Start date:
June 03, 2022
Estimated Completion Date:
March 31, 2025

Study 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 Hamilton Health Sciences (McMaster University).

Connect with a study center

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2X8
    Canada

    Active - Recruiting

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