LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring FMT, Microbiome
Eligibility Criteria
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
Sites / Locations
- University of Alberta HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
LFMT capsules + vedolizumab
Placebo capsules + vedolizumab
LFMT capsules + ustekinumab
Placebo capsules + ustekinumab
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.
The initial loading dose is 15 capsules, administered on day 0, in the clinic under direct observation, followed by 5 capsules daily starting on day 1 for 8 weeks at home. All subsequent doses will be dispensed to participants.
The placebo capsules will appear identical to the LFMT capsules; however, the capsules will contain 2 ingredients: trehalose and neusilin, which are components in LFMT capsules.