García Gissel, Soto Josanne, Díaz Antonio, Barreto Jesús, Soto Carmen, Pérez Ana Beatriz, Boffill Suselys, Gutiérrez Ángela, Cano Raúl de Jesús
Pathology Department, Clinical Hospital "Hermanos Ameijeiras", Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, Cuba.
Clinical Laboratory Department, Clinical Hospital "Hermanos Ameijeiras", Calle San Lázaro No 701, Esq. a Belascoaín, La Habana 10400, Cuba.
Microorganisms. 2024 Dec 13;12(12):2584. doi: 10.3390/microorganisms12122584.
(1) Background: , a lactic acid-producing bacterium, displays characteristics of both and genera. Clinical evidence suggests its potential health benefits. This study evaluated the safety of AO1167B as a candidate probiotic supplement. (2) Methods: Strain identification was confirmed through morphological, cultural, and genomic analyses, including 16S RNA and whole genome sequencing to assess antimicrobial resistance and virulence factors. Phenotypic tests, such as disk diffusion for antimicrobial resistance, and safety assays for cytotoxicity and hemolytic activity, were conducted. In a phase I, double-blind, placebo-controlled clinical trial, healthy adults were randomized into AO1167B and placebo groups for 60 days. Daily capsule consumption was monitored through clinical and hematological evaluations, adverse event tracking, and health surveys. (3) Results: The genome of AO1167B revealed no concerning features. Disk diffusion tests showed no antimicrobial resistance. The strain exhibited no cytotoxic or hemolytic activity, indicating in vitro safety. No significant differences in clinical or hematological parameters were observed between groups. The most common adverse event, gas, diminished over time. (4) Conclusions: AO1167B demonstrates a suitable safety profile, genetic stability, and probiotic potential for gastrointestinal health, justifying further clinical research.
(1) 背景：产乳酸细菌AO1167B兼具芽孢杆菌属和乳杆菌属的特征。临床证据表明其具有潜在的健康益处。本研究评估了AO1167B作为候选益生菌补充剂的安全性。(2) 方法：通过形态学、培养和基因组分析（包括16S RNA和全基因组测序）来确认菌株鉴定，以评估抗菌抗性和毒力因子。进行了表型测试，如抗菌抗性的纸片扩散法，以及细胞毒性和溶血活性的安全性测定。在一项I期双盲、安慰剂对照临床试验中，健康成年人被随机分为AO1167B组和安慰剂组，为期60天。通过临床和血液学评估、不良事件跟踪和健康调查来监测每日胶囊服用情况。(3) 结果：AO1167B的基因组未显示出相关特征。纸片扩散试验显示无抗菌抗性。该菌株未表现出细胞毒性或溶血活性，表明其在体外具有安全性。两组之间在临床或血液学参数上未观察到显著差异。最常见的不良事件——气体，随时间推移而减少。(4) 结论：AO1167B显示出适宜的安全性概况、遗传稳定性以及对胃肠道健康有益生菌潜力，为进一步的临床研究提供了依据。
