Drug intelligence / Profile preview

Fecal microbiota transplantation (Memorial University of Newfoundland)

Development stage
Unknown
Lead developer
Memorial University of Newfoundland
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
01

Overview

This investigational fecal microbiota transplantation (FMT) product, developed by the Memorial University of Newfoundland, is an oral, encapsulated formulation of live commensal bacteria derived from healthy donor stool. Unlike traditional FMT, which is typically reserved for recurrent *Clostridium difficile* infections and administered via invasive routes, this specific product is being evaluated in Phase 3 clinical trials as a primary (first-line) therapy for *Clostridium difficile*-associated diarrhea (CDAD). The treatment aims to rapidly restore the diversity and functional integrity of the gut microbiome, which is often depleted by antibiotic use. By reintroducing a complex microbial ecosystem, the therapy provides colonization resistance against *C. difficile* through nutrient competition, niche exclusion, and the restoration of secondary bile acid metabolism, which inhibits the germination and vegetative growth of the pathogen.

Other names
Oral encapsulated FMTFMT capsulesFecal microbiota transplantation capsules

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