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non-toxigenic Clostridioides difficile

Development stage: Unknown
Lead developer: Leiden University Medical Center
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

NTCD (Non-Toxigenic *Clostridioides difficile*) is a live biotherapeutic product consisting of spores from a *C. difficile* strain that lacks the genes for toxins A and B. It is being developed as a preventive strategy for *Clostridioides difficile* infection (CDI). The primary mechanism of action is competitive exclusion, where the non-toxigenic strain colonizes the gastrointestinal tract and outcompetes pathogenic, toxigenic strains for essential nutrients and mucosal binding sites. This colonization prevents the overgrowth of toxin-producing bacteria, particularly following antibiotic-induced dysbiosis. Clinical research, including studies led by Leiden University Medical Center, has focused on evaluating the safety, tolerability, and colonization efficiency of NTCD spores in healthy volunteers and patients at risk of recurrent CDI.

Other names: non-toxigenic Clostridioides difficile sporesnon-toxigenic C. difficile

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