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**Bifidobacterium bifidum OLB6378** is a specific probiotic bacterial strain of *Bifidobacterium bifidum* developed by **Meiji** for infant use, especially in preterm and very low birth weight infants. The strain is also identified as **NITE BP-31** and has been studied in both live and heat-treated non-live forms. It functions as a microbiome-directed immunomodulator rather than a single-receptor drug, with reported activity including enhancement of mucosal and systemic humoral immunity, increased secretory IgA production, and upregulation of polymeric immunoglobulin receptor expression. Public clinical and publication records describe oral administration to preterm or low birth weight infants for prevention of complications such as necrotizing enterocolitis, late-onset sepsis, delayed enteral feeding, and impaired growth, and also support its use as an ingredient in infant formula. The asset is best characterized as a strain-specific probiotic or microbial therapy rather than a conventional small-molecule pharmaceutical.
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