Phase
Condition
Ulcerative Colitis
Ulcers
Bowel Dysfunction
Treatment
Lyophilized fecal microbiota (LFMT)
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 standardendoscopic and histologic criteria
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
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
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
Willing and able to comply with all required study procedures
Exclusion
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 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
Pregnant or lactating
Unwilling to discontinue non-dietary probiotic
Antibiotic use in the past 30 days or anticipated need for systemic antibiotic useduring 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
Study Design
Study Description
Connect with a study center
University of Alberta Hospital
Edmonton, Alberta T6G 2X8
CanadaActive - Recruiting
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