Data_Sheet_1_Effects of a Probiotic Formulation on Seasonal Allergic Rhinitis in Adults—A Randomized Double-Blind Placebo-Controlled Trial: The Probiotics for Hay Fever Trial.PDF

BackgroundSeasonal-allergic-rhinitis (hay fever) affects approximately 4.6 million (20%) Australians each year. Hay fever manifests as runny/blocked nose and often itchy/sore/swollen eyes, with symptoms greatly impacting the quality of life. Rescue medications such as antihistamines are often needed to restore function, but they may trigger some other unwanted side effects. Probiotics have shown promise to reduce hay fever symptoms.
ObjectiveIn this randomized double-blind placebo-controlled 12-week trial, we aimed to assess the tolerability and efficacy of the probiotic formula “NC-Seasonal-Biotic” on symptoms, quality-of-life, and immunological and microbial factors.
MethodsAdults, who had previously suffered from hay fever symptoms, were screened for eligibility and randomly allocated to probiotic or placebo trial powder. Treatment effectiveness was assessed by questionnaires, daily total-nasal-symptom-score, and weekly rhinoconjunctivitis quality-of-life questionnaire. Secondary outcome measures included immunological parameters such as T-cell immunity (Th1/Th2 ratio) and the stool-microbiome analysis. Tolerability was assessed weekly by the gastrointestinal symptom scale.
ResultsRecruitment and follow-up were challenging around the 2020/2021 hay fever season in Melbourne, Australia, due to the harsh COVID-19 restrictions and extended lockdowns. Out of the 82 adults enrolled in this study, 75% participated (n = 60), and half (n = 40) completed the 10–12-week intervention period. In the intention-to-treat analysis, no significant differences in hay fever symptoms were apparent between the groups, while quality-of-life trended toward greater improvement in the active group. Intention-to-treat analysis was confounded due to a third of all participants not completing the full 10–12-week-intervention period. Subgroup analyses of the participants (n = 40) completing the full 10–12-week study period revealed a significantly greater reduction in symptoms in the active group compared with the placebo group, including runny nose (p = 0.04) and itchy eyes (p = 0.01). Furthermore, the active group reported significant improvements in the quality-of-life, including more functionality during the day (p = 0.05), better sleep (p = 0.005), less fatigue (p = 0.04), less thirst (p = 0.007), and less irritability (p = 0.007). Immunological parameters, measured by T-helper cell ratio (Th1/Th2), improved significantly in the active group compared with the placebo group. Most microbial changes were not statistically different between the groups. The trial powder was generally well tolerated.
ConclusionOur study suggests the probiotic formula “NC-Seasonal-Biotic,” taken for 10–12 weeks, as effective in reducing hay fever symptoms, such as runny nose and itchy eyes, and improved the quality-of-life and immunological parameters while being well tolerated.
Clinical Trial Registration[www.ClinicalTrials.gov], identifier [ACTRN126200 01078943].

背景：季节性过敏性鼻炎（Seasonal-allergic-rhinitis，即花粉症hay fever）每年影响约460万（占澳大利亚总人口20%）民众。花粉症临床表现为流涕、鼻塞，常伴随眼痒、眼痛、眼肿，其症状严重影响患者生活质量。临床通常需使用抗组胺药等急救药物以缓解症状，但此类药物可能引发多种不良副作用。现有研究显示，益生菌可有效减轻花粉症症状。
研究目的：本项随机双盲安慰剂对照12周临床试验，旨在评估益生菌制剂"NC-Seasonal-Biotic"对花粉症症状、生活质量，以及免疫学与微生物学相关指标的耐受性与疗效。
研究方法：本研究纳入既往确诊花粉症的成年受试者，经资格筛查后，将其随机分配至益生菌组或安慰剂组，服用对应试验用粉剂。疗效评估通过问卷、每日总鼻部症状评分（total-nasal-symptom-score）以及每周鼻结膜炎生活质量问卷（rhinoconjunctivitis quality-of-life questionnaire）完成。次要结局指标包括T细胞免疫（T-cell immunity，即Th1/Th2比值）等免疫学参数，以及粪便微生物组分析（stool-microbiome analysis）。受试者的耐受性则通过每周胃肠道症状量表进行评估。
研究结果：受2020/2021年澳大利亚墨尔本地区严苛的新冠疫情防控政策与长期封控措施影响，本试验在花粉季期间的招募与随访工作面临诸多挑战。本研究共纳入82名成年受试者，其中75%（n=60）完成入组后的随访流程，另有半数（n=40）完成了10~12周的完整干预疗程。在意向治疗分析（intention-to-treat analysis）中，两组受试者的花粉症症状未呈现显著差异，但活性益生菌组的生活质量评分呈现出更优的改善趋势。由于约三分之一的受试者未完成完整的10~12周干预疗程，意向治疗分析结果存在混杂偏倚。对完成全部10~12周研究周期的40名受试者进行亚组分析（subgroup analyses）后发现，与安慰剂组相比，活性益生菌组的症状缓解更为显著，其中流涕症状（p=0.04）与眼痒症状（p=0.01）的改善均具有统计学意义。此外，活性益生菌组的生活质量得到显著提升，具体表现为日间活动能力改善（p=0.05）、睡眠质量提升（p=0.005）、疲劳感减轻（p=0.04）、口渴感缓解（p=0.007）以及易怒情绪改善（p=0.007）。免疫学参数方面，通过辅助性T细胞比值（Th1/Th2）检测发现，活性益生菌组的指标改善程度显著优于安慰剂组。两组受试者的多数微生物组变化无统计学差异。试验用制剂整体耐受性良好。
结论：本研究表明，连续服用10~12周的益生菌制剂"NC-Seasonal-Biotic"可有效减轻花粉症症状（如流涕与眼痒），同时提升受试者的生活质量与免疫学参数水平，且整体耐受性良好。
临床试验注册：注册平台为www.ClinicalTrials.gov，试验编号为ACTRN12620001078943。