Drug intelligence / Profile preview

Bifidobacterium longum BB536

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 longum BB536 is a clinically effective, well-established multifunctional probiotic strain originally isolated from a healthy infant. It is classified as a human-residential bifidobacteria (HRB) and has been used for over 50 years in humans to alleviate gastrointestinal, immunological, and infectious diseases. The strain produces lactic and acetic acid in the gut and is known for its ability to colonize the human intestine effectively[1][2][4]. Its primary mechanism of action involves modulation of the gut microbiota, enhancement of intestinal barrier function, production of beneficial metabolites (such as short-chain fatty acids), and immune system modulation[1][4]. Clinical studies have shown benefits in improving chronic constipation in elderly individuals[1], reducing symptoms of irritable bowel syndrome (IBS) in children[4], alleviating allergic symptoms such as Japanese cedar pollen allergy[5], supporting gut health after antibiotic or radiation exposure[5], and maintaining general digestive health. The strain is non-pathogenic, non-toxigenic, Generally Recognized As Safe (GRAS) by the FDA for use in foods including infant formula powder[3][6]. It is developed and manufactured by Morinaga Milk Industry.

Brand names
Probiotic-Pro BB536
Other names
Bifidobacterium longum subsp. longum BB536B. longum BB536

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