Safety evaluation of pasteurized Akkermansia muciniphila YGMCC2645

Due to the potential benefits of Akkermansia muciniphila (A. muciniphila) to humans, it is considered a promising next-generation probiotic. To better develop and utilise A. muciniphila, a systematic safety assessment is necessary. This study involved conducting a series of tests to determine the safety of pasteurized A. muciniphila YGMCC2645. Results were shown that there was no antibiotic-resistance, virulence, and pathogenicity genes in the YGMCC2645. The LD₅₀ of acute oral toxicity in rats was greater than 10.0 g/kg BW (3.0 × 10¹² TFU/kg BW). No genotoxicity was found in the Ames test, the chromosome aberration mammalian assay, or the erythrocyte micronucleus assay. In the 90-day oral toxicity (with a dose of up to 2.5 × 10¹¹ TFU/kg BW), no treatment-related toxicological changes were observed in terms of body weight, food intake, food efficiency, hematological and biochemical indexes, urine indexes, and pathological indexes. In terms of teratogenic toxicity, there were no significant differences in the reproductive parameters of pregnant rats and developmental parameters of fetal rats. These results supported A. muciniphila YGMCC2645 is safe for use as a food ingredient.