Han Kwon Il, Shin Hyun-Dong, Lee Yura, Baek Sunhwa, Moon Eunjung, Park Youn Bum, Cho Junhui, Lee Jin-Ho, Kim Tack-Joong, Manoharan Ranjith Kumar
Research and Development Center, Bereum Co., Ltd., Wonju 26361, Republic of Korea.
Division of Biological Science and Technology, Yonsei University, Wonju 26493, Republic of Korea.
Pharmaceuticals (Basel). 2024 Oct 17;17(10):1383. doi: 10.3390/ph17101383.
Probiotics, which are live microorganisms that, when given in sufficient quantities, promote the host's health, have drawn a lot of interest for their ability to enhance gut health. , a member of the human gut microbiota, has shown promise as a probiotic candidate due to its functional attributes. However, safety concerns associated with certain strains warrant comprehensive evaluation before therapeutic application.
In this study, EF-2001, originally isolated from fecal samples of a healthy human infant, was subjected to a multi-faceted assessment for its safety and probiotic potential. In silico analysis, CAZyme, biosynthetic, and stress-responsive proteins were identified.
The genome lacked biogenic amine genes but contained some essential amino acid and vitamin synthetic genes, and carbohydrate-related enzymes essential for probiotic properties. The negligible difference of 0.03% between the 1 and 25 generations indicates that the genetic information of the EF-2001 genome remained stable. The live EF-2001 ( EF-2001L) demonstrated low or no virulence potential, minimal D-Lactate production, and susceptibility to most antibiotics except some aminoglycosides. No bile salt deconjugation or biogenic amine production was observed in an in vitro assay. Hemolytic activity assessment showed a β-hemolytic pattern, indicating no red blood cell lysis. Furthermore, the EF-2001L did not produce gelatinase and tolerated simulated gastric and intestinal fluids in an in vitro study. Similarly, heat-killed EF-2001 ( EF-2001HK) exhibits tolerance in both acid and base conditions in vitro. Further, no cytotoxicity of postbiotic EF-2001HK was observed in human colorectal adenocarcinoma HT-29 cells.
These potential properties suggest that probiotic and postbiotic EF-2001 could be considered safe and retain metabolic activity suitable for human consumption.
益生菌是一类活的微生物，当给予足够数量时可促进宿主健康，因其增强肠道健康的能力而备受关注。作为人类肠道微生物群的一员，由于其功能特性，已显示出作为益生菌候选者的潜力。然而，与某些菌株相关的安全问题在治疗应用前需要进行全面评估。
在本研究中，最初从一名健康人类婴儿的粪便样本中分离出的EF-2001，对其安全性和益生菌潜力进行了多方面评估。通过计算机分析，鉴定了碳水化合物活性酶、生物合成和应激反应蛋白。
该基因组缺乏生物胺基因，但含有一些必需氨基酸和维生素合成基因，以及益生菌特性所必需的碳水化合物相关酶。第1代和第25代之间0.03%的可忽略不计的差异表明EF-2001基因组的遗传信息保持稳定。活的EF-2001（EF-2001L）显示出低毒或无毒力潜力，D-乳酸产生极少，并且除了一些氨基糖苷类抗生素外，对大多数抗生素敏感。在体外试验中未观察到胆汁盐去结合或生物胺产生。溶血活性评估显示为β-溶血模式，表明没有红细胞裂解。此外，在体外研究中，EF-2001L不产生明胶酶并且耐受模拟胃液和肠液。同样，热灭活的EF-2001（EF-2001HK）在体外的酸性和碱性条件下均表现出耐受性。此外，在人结肠腺癌HT-29细胞中未观察到后生型EF-2001HK的细胞毒性。
这些潜在特性表明，益生菌和后生型EF-2001可被认为是安全的，并保留适合人类食用的代谢活性。
