一个全面的毒理安全评估
Vickie Modica1, Róbert Glávits2, Amy Clewell1
1AIBMR Life Sciences, Inc., Seattle, WA, USA.
International journal of toxicology
|August 29, 2025
概括
评估了产生乳酸盐的细菌 Anaerostipes caccae CLB101 的安全性. 研究在老鼠中没有发现基因毒性或不良反应,从而确定了人类消费潜在的无观察不良反应水平 (NOAEL).
科学领域:
- 微生物学和毒理学
- 肠道微生物组研究
背景情况:
- 甲状腺菌 CLB101 是从婴儿便中分离出来的无氧细菌.
- 它产生酸盐,并可能促进微生物群的健康.
- 对于A.caccae菌株没有先前的毒性数据.
研究的目的:
- 评估A.caccae CLB101的基因毒性和一般毒性潜力.
- 确定潜在的人类消费的安全性.
主要方法:
- 由于无氧性,使用体内彗星和微核试验评估的基因毒性.
- 在Wistar大鼠中进行90天的重复剂量口服毒性研究 (0-1000 mg/kg/天).
- 评估包括临床症状,体重,食物消耗,临床病理,器官重量和组织病理.
主要成果:
- 在基因毒性测定中没有发现克拉斯托基性或血管新生性.
- 在90天的研究中,在所有测试剂量的老鼠中没有观察到任何不良反应.
- 没有观察到的不良影响水平 (NOAEL) 为1000 mg/kg bw/day (1.9 × 10^11 CFU/kg bw/day).
结论:
- 甲类甲 CLB101 没有表现出遗传毒性或显著的毒理问题.
- 这项研究证实了A. caccae CLB101对人类的潜在安全性.
- 高的NOAEL表明这种益生菌候选物的安全性.
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