Yen Chieh-Hung, Chang Yu-Wei, Sun Yen-Ling, Hung Yi-Yun, Liao Wei-Chieh, Lu Tsung-Han, Huang Pin-Chao, Chang Han-Hsin, Lin Meei-Yn, Lin David Pei-Cheng
Department of Ophthalmology, Jen-Ai Hospital, Taichung 412224, Taiwan.
Department of Ophthalmology, Chang Gung Memorial Hospital at Linkou, Taoyuan 333423, Taiwan.
Biomedicines. 2025 Apr 10;13(4):931. doi: 10.3390/biomedicines13040931.
: A probiotic (iHA318) has been demonstrated to alleviate dry eye symptoms in a mouse model. This study investigated its effects on dry eye mitigation in a clinical trial. : A total of 68 volunteers were recruited in the double-blind clinical trial and randomly divided into a probiotic group and a placebo group. The probiotic group received iHA318 capsules daily for 35 days via oral intake, while the placebo group received microcrystalline cellulose capsules. Assessments before and after the intervention were performed for the tear volume (TV), tear break-up time (TBUT), tear osmolarity (Osmo), serum sialic acid (SA) concentrations, and the Ocular Surface Disease Index (OSDI), and an impression cytology analysis was conducted for immunofluorescence detection of NLRP3 expression. : The tear volume was significantly increased in the probiotic group, although a placebo effect was observed in the placebo group. The probiotic group showed a significant reduction in tear osmolarity, an extended TBUT, and an improved OSDI score. These parameters were also observed in the placebo group without statistical significance. In addition, the serum SA was significantly increased in the probiotic group in contrast to a slight non-significant increase in the placebo group. Reductions in NLRP3 inflammasome activation and OSDI were found only in the probiotic group. : In conclusion, a significant improvement in major dry eye symptoms after iHA318 treatment was observed compared to the placebo group.
一种益生菌（iHA318）已被证实在小鼠模型中可缓解干眼症状。本研究在一项临床试验中调查了其对减轻干眼的作用。：在双盲临床试验中招募了68名志愿者，并随机分为益生菌组和安慰剂组。益生菌组通过口服每日服用iHA318胶囊，持续35天，而安慰剂组服用微晶纤维素胶囊。在干预前后对泪液量（TV）、泪膜破裂时间（TBUT）、泪液渗透压（Osmo）、血清唾液酸（SA）浓度和眼表疾病指数（OSDI）进行评估，并进行印迹细胞学分析以检测NLRP3表达的免疫荧光。：益生菌组的泪液量显著增加，尽管在安慰剂组中观察到了安慰剂效应。益生菌组的泪液渗透压显著降低，TBUT延长，OSDI评分改善。在安慰剂组中也观察到了这些参数，但无统计学意义。此外，与安慰剂组略有非显著性增加相比，益生菌组的血清SA显著增加。仅在益生菌组中发现NLRP3炎性小体激活和OSDI降低。：总之，与安慰剂组相比，iHA318治疗后主要干眼症状有显著改善。
