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Drug intelligence / Profile preview
Bifidobacterium breve BBG-01
- Development stage
- Phase 3
- Lead developer
- Yakult Honsha
- 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
01
Overview
Bifidobacterium breve BBG-01 is a live probiotic bacterial strain investigated for the prevention of necrotising enterocolitis (NEC), late-onset sepsis, and mortality in very preterm infants. The strain was the subject of the Probiotics in Preterm infantS (PiPS) trial, a large-scale Phase 3 study sponsored by Queen Mary, University of London. The proposed mechanism of action involves the colonization of the neonatal gut to improve intestinal barrier integrity and modulate the local immune response, potentially reducing the translocation of pathogens. Despite its theoretical benefits, the PiPS trial results indicated no significant difference between the probiotic and placebo groups in reducing the incidence of NEC or sepsis.
- Other names
- Bifidobacterium breve strain BBG-01
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