Lee Jin-Joo, Kim Kyung-Min, Kim Hyeon-Jeong, Sohn Johann, Song Ji-Won, Koo Hye-Yeon, Lee Seunghun
Biohealthcare R&D Center, Hyundai Bioland Co., Ltd., Manhae-ro, Danwon-gu, Ansan 15407, Republic of Korea.
Department of Family Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Republic of Korea.
Microorganisms. 2024 Oct 21;12(10):2109. doi: 10.3390/microorganisms12102109.
The gut microbiota can play an important role in enhancing the host's complex immune system. In this regard, many studies indicate that probiotics consumption has a beneficial impact on alterations in the composition of the gut microbiota. Our previous study demonstrated that the oral administration of HDB1258 (HDB1258) enhances immune cell activity and alters the composition of gut microbiota in C57BL/6 mice, thereby showing its potential as a novel immunostimulatory ingredient. Therefore, this clinical trial assessed the effects of HDB1258 on human natural killer (NK) cell activity and changes in gut microbiota. It also investigated the correlation between gut microbiota and NK cell activity following HDB1258 supplementation. Participants ( = 71) were randomized into placebo and HDB1258 groups, and NK cell activity and gut microbiota were investigated at baseline (week 0) and endline (week 8). The present study showed that HDB1258 significantly increased NK cell activity and resulted in positive regulatory effects on the gut microbial balance in subjects compared to the placebo group. HDB1258 affected the gut microbial balance by inducing the growth of beneficial bacteria such as and . Especially, the changes in - composition were negatively correlated with the changes in NK cell activity after HDB1258 consumption. There was also a positive correlation between the NK cell activity in the HDB1258 group and the composition of 9 and . These findings suggest that HDB1258 may improve the host's intestinal environment by regulating gut bacteria related to immune response and promote NK cell activation. This study was registered at clinical research information service (CRIS: KCT0008204).
肠道微生物群在增强宿主复杂的免疫系统方面可发挥重要作用。在这方面，许多研究表明，食用益生菌对肠道微生物群的组成变化具有有益影响。我们之前的研究表明，口服HDB1258可增强C57BL/6小鼠的免疫细胞活性并改变其肠道微生物群的组成，从而显示出其作为新型免疫刺激成分的潜力。因此，本临床试验评估了HDB1258对人类自然杀伤（NK）细胞活性和肠道微生物群变化的影响。它还研究了补充HDB1258后肠道微生物群与NK细胞活性之间的相关性。参与者（n = 71）被随机分为安慰剂组和HDB1258组，并在基线（第0周）和终点（第8周）时研究NK细胞活性和肠道微生物群。本研究表明，与安慰剂组相比，HDB1258显著提高了NK细胞活性，并对受试者的肠道微生物平衡产生了积极的调节作用。HDB1258通过诱导有益细菌如[具体细菌名称1]和[具体细菌名称2]的生长来影响肠道微生物平衡。特别是，[具体细菌名称1]组成的变化与食用HDB1258后NK细胞活性的变化呈负相关。HDB1258组的NK细胞活性与[具体细菌名称3]和[具体细菌名称4]的组成之间也存在正相关。这些发现表明，HDB1258可能通过调节与免疫反应相关的肠道细菌来改善宿主肠道环境并促进NK细胞活化。本研究已在临床研究信息服务中心（CRIS：KCT0008204）注册。
