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bifidobacterium BB-12 + lactobacillus paracasei + lactobacillus casei-431 + streptococcus thermophilus TH-4

Development stage: Phase 4
Lead developer: Chr. Hansen
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

This multi-strain probiotic combination consists of *Bifidobacterium animalis* subsp. *lactis* (BB-12), *Lactobacillus paracasei*, *Lactobacillus casei* (L. casei-431), and *Streptococcus thermophilus* (TH-4). It is currently being evaluated in a Phase 4 clinical trial led by Madiha (MPhil) to determine its efficacy in preventing necrotizing enterocolitis (NEC), sepsis, and feeding intolerance in preterm neonates. The mechanism of action involves the colonization of the neonatal gastrointestinal tract to establish a healthy microbiome, which strengthens the intestinal mucosal barrier, produces antimicrobial substances, and modulates the local immune response to prevent the overgrowth and translocation of pathogenic bacteria. These effects are intended to reduce systemic inflammation and improve growth outcomes in vulnerable premature infants.

Other names: Multiple Strain ProbioticsBB-12 + L. paracasei + L. casei-431 + TH-4

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