A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
• Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1)
• Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study.
• Female subjects of childbearing potential must have a negative urine Qualitative Human Chorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
• Willing and able to sign an informed consent form and attend all study-related clinic visits, assessments, and follow-up phone calls.
• Subject has an attending physician who will provide the non-FMT care.