LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Launched by UNIVERSITY OF ALBERTA · Apr 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a treatment called LFMT is when added to standard biologic therapies for patients with ulcerative colitis (UC). The trial is specifically looking at patients who are starting treatment with either vedolizumab or ustekinumab, which are medications used to help control UC symptoms. The goal is to see if adding LFMT can improve treatment outcomes compared to a placebo, which is an inactive substance that looks like the treatment but has no medical effect.

To participate in this trial, you need to be between 18 and 75 years old and diagnosed with active ulcerative colitis. This means your symptoms are currently active and have been confirmed by a doctor. You should also be starting biologic therapy for the first time or have not responded well to previous treatments. Participants will be monitored closely throughout the study, and it’s important to follow all instructions provided by the research team. If you meet these criteria and are interested, this trial could be an opportunity to help find new ways to manage ulcerative colitis.

Gender

ALL

Eligibility criteria

• 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 standard endoscopic and histologic criteria
• • 4. 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
• 5. 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
• • 6. 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
• • 7. Willing and able to comply with all required study procedures
• 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 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
• • 6. Pregnant or lactating
• • 7. Unwilling to discontinue non-dietary probiotic
• • 8. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
• • 9. FMT within 3 months prior to enrollment
• 10. Use of the following medications:
• • 1. rectal/topical therapy within 2 weeks of screening
• • 2. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
• • 3. tofacitinib within 4 weeks of screening
• • 4. adalimumab or infliximab within 8 weeks of screening
• • 5. vedolizumab within 8 weeks of screening
• • 6. ustekinumab within 12 weeks of screening
• • 7. prednisone \> 30 mg/d
• • 11. Investigator deems enrolment in the study is not in the best interest of the patient