LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

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 University of Manitoba.

Inclusion criteria

• 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 criteria

• 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