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首页> 外文期刊>Functional Foods In Health And Disease >Intake safety of Lactobacillus helveticus SBT2171 and its effects on nasal and ocular symptoms associated with mites and house dust: An open-label study and a randomized, double-blind, placebo-controlled, parallel group study
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Intake safety of Lactobacillus helveticus SBT2171 and its effects on nasal and ocular symptoms associated with mites and house dust: An open-label study and a randomized, double-blind, placebo-controlled, parallel group study

机译：瑞士乳杆菌SBT2171的摄入安全性及其对与螨虫和屋尘有关的鼻和眼症状的影响：一项开放标签研究和一项随机，双盲，安慰剂对照，平行组研究

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Background: We previously reported that Lactobacillus helveticus SBT2171 (LH2171) inhibited the proliferation and secretion of lipopolysaccharide-stimulated inflammatory cytokines in primary immune cells. Furthermore, in vivo administration of LH2171 has been demonstrated to suppress the incidence and development of murine rheumatoid arthritis. In this study, we evaluated whether the intake of drinkable yogurt (DY) containing LH2171 alleviated nasal and ocular symptoms of allergy to mites and house dust allergens. The safety of LH2171 was also confirmed in an independent, open-label study in 20 healthy subjects who consumed an excessive amount of LH2171.Methods: In study 1, the effect of daily intake of DY containing LH2171 for 12 weeks on nasal and ocular symptoms was evaluated in healthy men and women who tested positive for house dust or mite-specific IgE in a randomized, double-blind, placebo-controlled, parallel group study. One hundred subjects were divided into two groups: subjects taking placebo DY (P group, n = 50) and subjects taking DY containing approximately 1 × 10 9 cells of LH2171 (LH2171 group, n = 50) daily for the 12 weeks. After excluding subjects that met exclusion criteria, data obtained from 94 subjects (LH2171 group: n = 48; P group: n = 46) were analyzed to establish LH2171 efficacy. LH2171 safety was assessed in an independent, open-label trial in 20 subjects (study 2) who consumed an excessive amount of DY containing approximately 3 × 10 9 LH2171 cells.Results: In study 1, the decreases in the total scores of the nasal and ocular discomfort between week 0 and week 8 in LH2171 group were significantly larger than those in P group. Additionally, the number of sneezes decreased significantly in LH2171 group compared with P group on weeks 9–12 compared to the number of sneezes at baseline. In study 2, no adverse effects of LH2171 on systolic bold pressure, diastolic blood pressure, pulse rate, body weight, blood and urinalysis parameters were reported. Clinical trial registration: UMIN000027791 (study 1), UMIN000029058 (study 2).Conclusion: Daily intake of LH2171 for 12 weeks may regulate immune function and improve nasal and ocular symptoms in the subjects with mite or house dust allergy.
机译：背景：我们以前曾报道过瑞士乳杆菌SBT2171（LH2171）抑制脂多糖刺激的炎症细胞因子在原代免疫细胞中的增殖和分泌。此外，已证明体内施用LH2171可抑制鼠类风湿性关节炎的发生和发展。在这项研究中，我们评估了摄入含LH2171的可饮用酸奶（DY）是否能缓解对螨和屋尘过敏原过敏的鼻和眼症状。一项独立的，开放标签的研究还证实了LH2171的安全性，该研究针对20名摄入过量LH2171的健康受试者。方法：在研究1中，每天摄入含LH2171的DY 12周对鼻和眼症状的影响在一项随机，双盲，安慰剂对照，平行分组研究中，健康男性和女性的房尘或螨特异IgE检测呈阳性，对此进行了评估。将一百名受试者分为两组：服用安慰剂DY的受试者（P组，n = 50）和服用DY的受试者，在12周内每天包含约1×10 9个LH2171细胞（LH2171组，n = 50）。在排除符合排除标准的受试者后，分析从94名受试者（LH2171组：n = 48; P组：n = 46）获得的数据以建立LH2171疗效。在一项独立的，开放标签的试验中，对20名受试者（研究2）消耗了过量的DY，其中含有大约3×10 9 LH2171细胞，评估了LH2171的安全性。结果：在研究1中，鼻腔总得分的下降LH2171组第0周至第8周的眼部不适明显大于P组。此外，与基线时的打喷嚏次数相比，LH2171组在第9-12周的打喷嚏次数与P组相比明显减少。在研究2中，没有报道LH2171对收缩期大胆压力，舒张压，脉搏率，体重，血液和尿液分析参数的不利影响。临床试验注册：UMIN000027791（研究1），UMIN000029058（研究2）。结论：每天摄入LH2171达12周可调节螨虫或屋尘过敏受试者的免疫功能并改善鼻和眼症状。

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