Ma Xin, Tian Meng, Yu Xueping, Liu Ming, Li Bin, Ren Dayong, Wang Wei
State Key Laboratory of Bioreactor Engineering, East China University of Science and Technology, Shanghai 200237, China.
College of Food Science and Engineering, Jilin Agricultural University, Changchun 130118, China.
Foods. 2024 Jan 30;13(3):442. doi: 10.3390/foods13030442.
In addition to providing certain health advantages to the host, a bacterial strain must possess a clearly defined safety profile to be regarded as a probiotic. In this study, we present a thorough and methodical assessment of the safety of a novel strain of bacteria, PROBIO, which was isolated from human feces. Firstly, we examined the strain's overall features, such as its gastrointestinal tolerance and its physiological and biochemical traits. Next, we verified its genotoxic properties through bacterial reverse mutation and in vitro mammalian cell micronucleus assays. The drug sensitivity of PROBIO was subsequently examined through an analysis of its antibiotic resistance genes. Additionally, the toxicological impact was verified through acute and sub-chronic toxicity studies. A genome-based safety assessment was conducted to gain further insights into gene function, including potential virulence factors and pathogenic properties. Finally, we assessed whether moxifloxacin resistance in PROBIO is transferred using in vitro conjugation experiments. PROBIO exhibited superior gastrointestinal tolerance, with no observed hematological or histopathological abnormalities. Moreover, the outcomes pertaining to mutagenic, clastogenic, or toxic impacts were found to be negative, even at exceedingly high dosages. Moreover, no adverse effects associated with the test substance were observed during the examination of acute and sub-chronic toxicity. Consequently, it was plausible to estimate the no-observed-adverse-effect level (NOAEL) to be 6.4 × 10 viable bacteria for an average individual weighing 70 kg. Additionally, only three potential drug resistance genes and one virulence factor gene were annotated. PROBIO is naturally resistant to moxifloxacin, and resistance does not transfer. Collectively, the data presented herein substantiate the presumed safety of PROBIO for its application in food.
除了给宿主带来某些健康益处外，一种细菌菌株要被视为益生菌，必须具备明确界定的安全概况。在本研究中，我们对从人类粪便中分离出的一种新型细菌菌株PROBIO的安全性进行了全面且系统的评估。首先，我们检查了该菌株的总体特征，如胃肠道耐受性以及生理和生化特性。接下来，我们通过细菌回复突变试验和体外哺乳动物细胞微核试验验证了其遗传毒性特性。随后通过分析其抗生素抗性基因来检测PROBIO的药物敏感性。此外，通过急性和亚慢性毒性研究验证了毒理学影响。进行了基于基因组的安全评估，以进一步深入了解基因功能，包括潜在的毒力因子和致病特性。最后，我们通过体外接合实验评估PROBIO中的莫西沙星耐药性是否会转移。PROBIO表现出卓越的胃肠道耐受性，未观察到血液学或组织病理学异常。此外，即使在极高剂量下，与诱变、致断裂或毒性影响相关的结果也呈阴性。而且，在急性和亚慢性毒性检查期间未观察到与受试物质相关的不良反应。因此，对于平均体重70公斤的个体，估计无观察到不良反应水平（NOAEL）为6.4×10个活细菌是合理的。此外，仅注释了三个潜在的耐药基因和一个毒力因子基因。PROBIO对莫西沙星天然耐药，且耐药性不会转移。总体而言，本文提供的数据证实了PROBIO在食品应用中的假定安全性。
