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fecal microbiota transplantation (VA Office of Research & Development)

Development stage: Discontinued
Lead developer: VA Office of Research & Development
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: Oral

Overview

Fecal microbiota transplantation (FMT) is an investigational biologic therapy consisting of fecal microbiota from healthy, screened donors. It was developed by the VA Office of Research and Development to prevent recurrent Clostridioides difficile infection (CDI). Administered as oral capsules, the therapy aims to restore a healthy gut microbiome. A Phase 2/3 randomized, double-blind, placebo-controlled trial called MATCH (CSP #2004) evaluated its efficacy in veterans. The study was stopped early due to futility, as it did not demonstrate a significant difference in reducing CDI recurrence or death at 56 days compared to placebo. [2, 5, 6] While not effective in this trial, the therapy was found to be safe and well-tolerated. [2]

Other names: Fecal Microbiota TherapyFMTmicrobiota-based product

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