A Review of Probiotic Ingredient Safety Supporting Monograph Development Conducted by the United States Pharmacopeia (USP)

Boyte, Marie-Eve; Akhtar, Nadeem; Koshy, Binu; Roe, Amy L.

doi:10.1080/19390211.2024.2314488

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2024

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Cited by 2 publications

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DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

Wallace,

Koturbash

2024

Journal of Dietary Supplements

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DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

Wallace,

Koturbash

2024

Journal of Dietary Supplements

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Unveiling Akkermansia muciniphila Akk11: A Comprehensive Genotypic and Phenotypic Safety Assessment

Wang,

Fan,

Dong

et al. 2024

Preprint

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Background As a beneficial next-generation microorganism, A. muciniphila is beginning to enter the market as a commercial product and positioning itself as a potential candidate for clinical therapy. This study aims to evaluate the safety and probiotic potential of the Akkermansia muciniphila Akk11 strain isolated from infant feces. Results Akk11 was identified as an anaerobic, Gram-negative strain with mucin-degrading capabilities, showing up to 98.36% genomic similarity to the type strain (ATCC BAA-835T) based on average nucleotide identity (ANI) analysis. Genotypic analysis revealed three putative genes, the blaLUS-1 gene encoding class A beta-lactamase, the adeF gene encoding a fusion protein belonging to resistance-nodule-cell division (RND) antibiotic efflux pump system and the elongation factor Tu (Ef-Tu) gene, respectively. These genes were found to be intrinsic, indicating a favorable profile for Akk11. Phenotypic tests showed that Akk11 was highly resistant to gentamicin, kanamycin and streptomycin, while producing no biogenic amines, D-/L-lactic acid or showing negative hemolytic activity. The strain showed good tolerance under gastrointestinal stress conditions, exhibited no cytotoxicity and showed strong adhesion to intestinal cells in vitro. Furthermore, no oral toxicity or genotoxicity was observed in vivo. Conclusion The Akk11 strain exhibits a robust safety profile and probiotic potential, with properties comparable to those of the type strain. Our research highlights a novel Akkermansia muciniphila strain, Akk11, which provides a promising new candidate for probiotic applications and warrants further commercial development.

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A Review of Probiotic Ingredient Safety Supporting Monograph Development Conducted by the United States Pharmacopeia (USP)

Cited by 2 publications

References 71 publications

DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

Unveiling Akkermansia muciniphila Akk11: A Comprehensive Genotypic and Phenotypic Safety Assessment

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