Drug intelligence / Profile preview

bifidobacterium breve M-16V

Development stage
Phase 4
Lead developer
Morinaga Milk Industry
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

Bifidobacterium breve M-16V is a well-researched probiotic strain of bacteria developed and manufactured by Morinaga Milk Industry Co., Ltd. [2, 6, 11] It is widely used, particularly for infants (including preterm and low-birth-weight infants), to support healthy development. [1, 2, 9, 10] The strain has been shown to promote the colonization of beneficial bacteria in the gut, improve gut barrier function, and modulate the immune system. [1, 8, 9] B. breve M-16V is studied for its potential to prevent or alleviate allergic diseases, such as atopic dermatitis, and necrotizing enterocolitis (NEC) in high-risk infants. [1, 5, 7, 10] Its mechanism involves balancing the immune response, often by suppressing Th2-mediated allergic reactions and promoting anti-inflammatory pathways. [2, 5, 8] It is commonly incorporated into infant formulas and dietary supplements and has received GRAS (Generally Recognized as Safe) status from the US FDA for use in these products. [2, 9]

Brand names
Morinaga Bifidus M-16V
Other names
B. breve M-16VBifidobacterium breve strain M-16V

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