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基于全基因组测序、表型和口服毒性分析的TWK10安全性评估

Safety Assessment of TWK10 Based on Whole-Genome Sequencing, Phenotypic, and Oral Toxicity Analysis.

作者信息

Hsu Han-Yin, Liao Yi-Chu, Lin Shih-Hsuan, Lin Jin-Seng, Lee Chia-Chia, Watanabe Koichi

机构信息

Culture Collection & Research Institute, SYNBIO TECH INC., Kaohsiung 82151, Taiwan.

Department of Animal Science and Technology, National Taiwan University, Taipei 10673, Taiwan.

出版信息

Microorganisms. 2022 Apr 7;10(4):784. doi: 10.3390/microorganisms10040784.

DOI:10.3390/microorganisms10040784
PMID:35456834
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9031848/
Abstract

TWK10 (TWK10), isolated from Taiwanese pickled cabbage, has been demonstrated to exert beneficial probiotic effects in both mice and humans. Here, we comprehensively assessed the safety of TWK10 using both in vivo and in vitro approaches, including whole-genome sequence analysis, an assessment of hemolytic activity, and performing an antimicrobial susceptibility test, the Ames bacterial reverse mutation assay, the chromosomal aberration test, a rodent peripheral blood micronucleus test, and the 28-day subacute oral toxicity assay. The results showed that there was no significant increase in the incidence of reverse mutations or chromosomal aberrations following exposure to TWK10. Moreover, no significant changes were detected either in the number of reticulocytes or the incidence of micronuclei in ICR mice, and no subacute toxicity was recorded in SD rats at the oral TWK10 dosage of 2000 mg/kg body weight/day repeated for 28 days. Additionally, TWK10 exhibited no hemolytic activity and was susceptible to all the antibiotics tested, except kanamycin. However, no antimicrobial resistance genes, virulence factors, or genes involved in biogenic amine synthesis were found in the genome of TWK10. Our findings demonstrated that TWK10 has high potential of being safe for human consumption as a probiotic.

摘要

从台湾泡菜中分离出的TWK10已被证明在小鼠和人类中均具有有益的益生菌作用。在此,我们使用体内和体外方法全面评估了TWK10的安全性,包括全基因组序列分析、溶血活性评估、抗菌药敏试验、Ames细菌回复突变试验、染色体畸变试验、啮齿动物外周血微核试验以及28天亚急性经口毒性试验。结果表明,暴露于TWK10后,回复突变或染色体畸变的发生率没有显著增加。此外,在ICR小鼠中,网织红细胞数量或微核发生率均未检测到显著变化,并且在以2000 mg/kg体重/天的剂量重复经口给予TWK10 28天的SD大鼠中未记录到亚急性毒性。此外,TWK10没有溶血活性,并且对除卡那霉素外的所有测试抗生素敏感。然而,在TWK10的基因组中未发现抗菌抗性基因、毒力因子或参与生物胺合成的基因。我们的研究结果表明,TWK10作为益生菌对人类食用具有很高的安全性潜力。

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