The University of Texas Health Science Center, Houston
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
Inclusion Criteria: 1. Adult ≥18 years of age 2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria. 3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy. 4. Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study. 5. Female subjects of childbearing potential must have a negative urine Qualitative HCG pregnancy test at enrolment and on the Week 1, Day 1 of the Treatment prior to adm…
Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.
Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
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