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fecal microbiota transplantation (University of North Carolina at Chapel Hill, f4a991)
- Development stage
- Unknown
- Lead developer
- University of North Carolina at Chapel Hill
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Oral, Rectal
01
Overview
Fecal microbiota transplantation (FMT) is an investigational live biotherapeutic therapy being developed by the University of North Carolina, Chapel Hill for the treatment of antibiotic-dependent pouchitis. Pouchitis is an inflammatory condition of the ileal pouch that can occur after surgery for ulcerative colitis, and it is believed to be driven by an imbalance in the gut bacteria (dysbiosis). [4, 7] FMT aims to restore a healthy gut microbial community by introducing fecal matter from a healthy, screened donor into the patient's gastrointestinal tract. [3, 7] This is hypothesized to correct the underlying dysbiosis, break the cycle of chronic inflammation, and reduce or eliminate the need for long-term antibiotic therapy. [6] The university is conducting a Phase 1/2 randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of this approach.
- Other names
- FMTfecal microbiome transplantation
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