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placebo FMT + FMT-University of North Carolina, Chapel Hill-pouchitis
- Development stage
- Unknown
- Lead developer
- University of North Carolina at Chapel Hill
- Modality
- Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Rectal, Oral
01
Overview
The query 'placebo FMT + FMT-University of North Carolina, Chapel Hill-pouchitis' refers to the intervention and placebo arms of a clinical trial rather than a specific drug product. [3] This was a randomized, placebo-controlled, double-blind Phase 1/2 trial (NCT02782325) sponsored by the University of North Carolina, Chapel Hill. [3] The active investigational therapy is a Fecal Microbiota Transplantation (FMT), a type of biologic and live microbiome therapy. [4] It was evaluated for the treatment of antibiotic-dependent pouchitis, an inflammatory condition of the ileal pouch that can occur after surgery for ulcerative colitis. [3, 7] The therapy, which consists of fecal microbiota from healthy donors, aims to restore microbial diversity in the gut. [4] The trial, which used an intensified regimen of endoscopic and oral FMT, ultimately showed limited clinical efficacy and low donor microbial engraftment. [5, 8]
- Other names
- fecal microbiota transplantFecal Microbiome TransplantationFMT
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