Lack of genotoxicity and subchronic toxicity in safety assessment studies of <i>Akkermansia muciniphila</i> formulation.

ABSTRACT: A powder formulation of viable Akkermansia muciniphila bacteria (AMUC) was evaluated in a 90-day repeated-dose toxicity study in rats and a battery of genotoxicity studies to evaluate AMUC as a food ingredient. All studies followed Organisation for Economic Co-operation and Development protocols (OECD TG 408, 471 473, 474). AMUC was administered to rats via gavage at 0, 500, 1000, and 2000 mg/kg body weight/day (equivalent to 0, 4.1 × 10¹⁰, 9.2 × 10¹⁰, and 1.64 × 10¹¹ CFU/kg body weight/day). No mortality or treatment-related adverse effects were reported in any endpoints that were attributed to AMUC consumption. No bacterial translocation of viable A. muciniphila from the intestinal tract was found to the liver, mesenteric lymph nodes,

SUBMITTER: Yu E 

PROVIDER: S-EPMC11565037 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature