In vitro and in vivo evaluation of efficacy and safety of Weizmannia coagulans HOM5301 for boosting immunity

[Display omitted] •The complete genome sequence of W. coagulans HOM5301 was assembled and analyzed.•W. coagulans HOM5301 showed goodinvitroprobioticcharacteristics.•Daily treatment with W. coagulans HOM5301 spores boosted immunity in mice.•W. coagulans HOM5301 positively modulated the gut microbiota in mice. Weizmannia coagulans is considered an ideal probiotic owing to its function and stability during production and storage. This study aims to evaluate the efficacy and safety of W. coagulans HOM5301 as an immunoregulatory probiotic. Whole genome analysis demonstrated that W. coagulans HOM5301 had no antibiotic resistance or virulence genes, but contained four gene clusters of secondary metabolites related to antimicrobial activities. W. coagulans HOM5301 spores tolerated gastrointestinal tract conditions with a survival rate of 86.33%. The spent culture broth of W. coagulans HOM5301 showed strong antimicrobial activity against foodborne pathogens. W. coagulans HOM5301 stimulated macrophages to produce more TNF-α but less IL-10 than that of the controls. Daily treatment with W. coagulans HOM5301 spores for 31 days positively modulated the gut microbiota and boosted both innate and adaptive immunity in a dose-dependent manner in mice. In conclusion, W. coagulans HOM5301 can be safely consumed by humans to induce robust immunity.