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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGPatients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3
Time frame: 9 months
Quality of life will be characterized by health-related quality of life score.
Time frame: 9 months
Subject-reported score in Hospital Anxiety and Depression Scale
After administering 12 weeks of PRIM-DJ2727
Time frame: 9 months
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