Proteon Pharmaceuticals S.A., Tylna 3a, 90-364 Łódź, Poland.
Viruses. 2020 Jul 10;12(7):742. doi: 10.3390/v12070742.
Bacteriophages are bacterial predators, which are garnering much interest nowadays vis-à-vis the global phenomenon of antimicrobial resistance. Bacteriophage preparations seem to be an alternative to antibiotics, which can be used at all levels of the food production chain. Their safety and efficacy, however, are of public concern. In this study, a detailed evaluation of BAFASAL preparation was performed. BAFASAL is a bacteriophage cocktail that reduces in poultry farming. In vivo acute and sub-chronic toxicity studies on rats and tolerance study on targeted animals (chicken broiler) conducted according to GLP and OECD guidelines did not reveal any signs of toxicity, which could be associated with BAFASAL administration. In addition, no evidences of genotoxicity were observed. The tolerance study with 100-times concentrated dose also did not show any statistically significant differences in the assessed parameters. The in vitro crop assay, mimicking normal feed storage and feed application conditions showed that BAFASAL reduced the number of bacteria in experimentally contaminated feed. Moreover, reductions were observed for all examined forms (liquid, powder, spray). Furthermore, the in vivo efficacy study showed that treatment with BAFASAL significantly decreased content in caeca of birds infected with Enteritidis. Detailed examination of BAFASAL in terms of safety and efficacy, adds to the body of evidence that bacteriophages are harmless to animals and effective in the struggle against bacteria.
噬菌体是细菌的捕食者，在全球范围内对抗生素耐药性的现象出现后，它们引起了广泛关注。噬菌体制剂似乎是抗生素的替代品，可以在食物链的各个层面使用。然而，它们的安全性和有效性引起了公众的关注。在本研究中，对 BAFASAL 制剂进行了详细评估。BAFASAL 是一种噬菌体鸡尾酒，可减少家禽养殖中的 。根据 GLP 和 OECD 指南对大鼠进行的体内急性和亚慢性毒性研究以及对目标动物（肉鸡）的耐受性研究未显示出与 BAFASAL 给药相关的任何毒性迹象。此外，没有观察到遗传毒性的证据。用 100 倍浓缩剂量进行的耐受性研究也没有显示评估参数有任何统计学上的显著差异。模拟正常饲料储存和饲料应用条件的体外作物测定表明，BAFASAL 减少了实验污染饲料中 细菌的数量。此外，所有检查形式（液体、粉末、喷雾）都观察到减少。此外，体内疗效研究表明，用 BAFASAL 治疗可显著降低感染 肠炎沙门氏菌的鸟类盲肠中的 含量。从安全性和有效性方面详细检查 BAFASAL，增加了噬菌体对动物无害且在对抗细菌方面有效的证据。
