LFMTLFMT vs Placebo in New Biologic Start for Ulcerative Colitis

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