García Gissel, Soto Josanne, Díaz Antonio, Barreto Jesús, Soto Carmen, Pérez Ana Beatriz, Boffill Suselys, Cano Raúl De Jesús
Pathology Department, Clinical Hospital "Hermanos Ameijeiras", Calle San Lázaro No 701, Esq. a Belascoaín, Centro Habana, La Habana 10400, Cuba.
Clinical Laboratory Department, Clinical Hospital "Hermanos Ameijeiras", Calle San Lázaro No 701, Esq. a Belascoaín, Centro Habana, La Habana 10400, Cuba.
Microorganisms. 2024 Nov 12;12(11):2299. doi: 10.3390/microorganisms12112299.
(1) Background: AO1125 is a Gram-positive, motile, spore-forming bacterium with potential as a probiotic due to its broad-spectrum antimicrobial activity, inhibiting pathogens like , , and , as well as anti-rotavirus activity. Its resilience in gastrointestinal conditions suggests benefits for gut health. This study evaluates the safety and probiotic potential of AO1125. (2) Methods: Genome annotation identified genes linked to probiotic traits such as stress resistance, gut colonization, immune modulation, and antimicrobial production. The genome was screened for antibiotic resistance genes using CARD, bacteriocin clusters using BAGEL4, and virulence factors via VFDB. Cytotoxicity was assessed on Vero cells and erythrocytes, and a Phase I, double-blind, placebo-controlled clinical trial was conducted with 99 healthy volunteers (50 AO1125, 49 placebo). (3) Results: Genomic analysis confirmed minimal antibiotic resistance genes and the absence of virulence factors, supporting safety. AO1125 showed no pathogenicity, cytotoxicity, or hemolytic activity and was well-tolerated in clinical settings, with mild, transient abdominal gas as the most common adverse event. (4) Conclusions: The safety profile and genetic basis for probiotic and antimicrobial properties support AO1125 as a promising probiotic candidate for gastrointestinal health, warranting further clinical research.
(1) 背景：AO1125是一种革兰氏阳性、具运动性、产芽孢的细菌，因其具有广谱抗菌活性，能抑制如[具体病原体名称未给出]等病原体，还具有抗轮状病毒活性，故而具有作为益生菌的潜力。其在胃肠道环境中的耐受性表明对肠道健康有益。本研究评估了AO1125的安全性和益生菌潜力。(2) 方法：基因组注释确定了与益生菌特性相关的基因，如抗逆性、肠道定殖、免疫调节和抗菌物质产生。使用CARD筛选基因组中的抗生素抗性基因，使用BAGEL4筛选细菌素簇，通过VFDB筛选毒力因子。在Vero细胞和红细胞上评估细胞毒性，并对99名健康志愿者（50名服用AO1125，49名服用安慰剂）进行了I期双盲、安慰剂对照临床试验。(3) 结果：基因组分析证实抗生素抗性基因极少且无毒力因子，支持其安全性。AO1125未表现出致病性、细胞毒性或溶血活性，在临床环境中耐受性良好，最常见的不良事件是轻度、短暂的腹部胀气。(4) 结论：其安全性概况以及益生菌和抗菌特性的遗传基础支持AO1125作为一种有前景的用于胃肠道健康的益生菌候选物，值得进一步开展临床研究。
