Drug intelligence / Profile preview

bacillus clausii

Development stage
Phase 4
Lead developer
Sanofi
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

Bacillus clausii is an orally administered spore-forming probiotic bacterium used as a therapeutic microbial product to help restore intestinal microbial balance, particularly during or after antibiotic exposure and in acute infectious diarrhea. Clinical-trial and publication evidence identifies it most prominently in Sanofi's Enterogermina program, including randomized studies in children with acute diarrhea, antibiotic-associated diarrhea prevention, and other gastrointestinal conditions. Its activity is not mediated through a single human receptor target; rather, proposed mechanisms include transient gut colonization, competitive effects on intestinal microbes, support of microbiota recovery, and immunomodulatory and antimicrobial effects of probiotic spores and metabolites. Commercial products exist both as pharmaceutical/consumer probiotic suspensions of spores and as region-specific marketed products from companies including Sanofi and LiveSpo Global.

Brand names
EnterogerminaErcefloraLiveSpo CLAUSYBiale Germin ForteBacipore
Other names
Bacillus clausii sporesBacillus clausii probiotic strainBacillus clausii O/CBacillus clausii N/RBacillus clausii SINBacillus clausii T
02

Targets

Shigella spp. (Shigella species)

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