Drug intelligence / Profile preview

Bifidobacterium longum BB536 + Bifidobacterium infantis M-63 + Bifidobacterium breve M-16V

Development stage
Unknown
Lead developer
University of Campania Luigi Vanvitelli
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

A probiotic mixture developed by the University of Campania Luigi Vanvitelli for the treatment of seasonal allergic rhinitis in children. The active ingredient is a combination of three specific Bifidobacterium strains: *Bifidobacterium longum* BB536, *Bifidobacterium infantis* M-63, and *Bifidobacterium breve* M-16V. This product functions as a biologic with anti-inflammatory and immune-modulatory properties, specifically targeting IgE-mediated inflammatory reactions associated with allergic rhinitis. A Phase 3 trial (NCT02807064) in children aged 4-17 demonstrated that daily administration for eight weeks significantly improved allergic rhinitis symptoms and quality of life compared to placebo. It is formulated as a powder in sachets and has been marketed as a Class I medical device.

Other names
bifidobacteria-University of Campania Luigi Vanvitelli

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