Bergmann Karl-Christian, Krause Linda, Hiller Julia, Becker Sylvia, Kugler Sebastian, Tapparo Martin, Pfaar Oliver, Zuberbier Torsten, Kramer Matthias F, Guethoff Sonja, Graessel Anke
Department for Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, And Berlin Institute of Health, Berlin, Germany.
ECARF - European Centre for Allergy Research Foundation, Berlin, Germany.
World Allergy Organ J. 2020 Dec 18;14(1):100494. doi: 10.1016/j.waojou.2020.100494. eCollection 2021 Jan.
Allergic rhinitis/rhinoconjunctivitis is the most common immune disease worldwide, but still largely underestimated, underdiagnosed, and undertreated. Dysbiosis and reduced microbial diversity is linked to the development of allergies, and the immunomodulatory effects of pro- and prebiotics might be used to counteract microbiome dysbiosis in allergy. Adequate symbiotic (multi-strain pro-, plus prebiotic) supplementation can be suggested as a complementary approach in the management of allergic rhinitis.
The effects of the daily intake of a symbiotic food supplement (combination of and with Fructo-Oligosaccharides) for 4 months in birch pollen allergic rhinoconjunctivitis patients were investigated for the first time in an allergen exposure chamber (AEC) allowing standardised, reproducible pollen exposure before and after intake.
Eligible patients were exposed to birch pollen (8000 pollen/m³ for 120 min) at the GALEN AEC, at baseline (V1) and final visit (V3) outside the season. The Total Symptom Score (TSS) and the scores for nose, eye, bronchial system, and others were evaluated every 10 min during exposure. Other secondary endpoints were the changes in well-being, Peak Nasal Inspiratory Flow (PNIF), lung function parameters, and safety. Co-primary endpoints were differences in Total Nasal Symptom Score (TNSS) and TSS after 120 min of exposure between both visits. Temporal evolution of symptom scores were analysed in an exploratory way using linear mixed effects models.
27 patients (mean age 45 years, 15% male) completed the study. Both co-primary endpoints showed significant improvement after intake of the symbiotic. Median TNSS and TSS were decreased 50% and 80% at 120 min (adjusted p-value = 0.025 and p < 0.01 respectively).All four symptom scores and the personal well-being, improved to a clinically relevant extent over time, visible by a weaker increase in symptoms during 120 min of the final birch pollen exposure. No relevant differences were observed for PNIF, PEF, and spirometry. There were no airway obstructions or lung restrictions before and after both exposures. Late phase reactions after exposure were reduced after V3, documenting a better birch pollen tolerability of the patients. The safety and tolerability profile of the symbiotic food supplement was excellent, no adverse events (AEs) were observed.
This first evaluation of a symbiotic food supplement in an AEC in rhinoconjunctivitis patients with or without asthma induced by birch pollen revealed a significant beneficial effect, harnessing significant improvements of symptoms and well-being while maintaining an excellent safety and tolerability profile.
变应性鼻炎/鼻结膜炎是全球最常见的免疫性疾病，但仍在很大程度上被低估、漏诊和治疗不足。微生物群失调和微生物多样性降低与过敏的发生有关，益生菌和益生元的免疫调节作用可用于对抗过敏中的微生物群失调。可以建议适当补充共生菌（多种菌株的益生菌加益生元）作为变应性鼻炎管理的一种补充方法。
首次在过敏原暴露室（AEC）中研究了桦树花粉变应性鼻结膜炎患者每日摄入共生食品补充剂（[具体菌株1]和[具体菌株2]与低聚果糖的组合）4个月的效果，该暴露室允许在摄入前后进行标准化、可重复的花粉暴露。
符合条件的患者在GALEN AEC中于季节外的基线（V1）和末次访视（V3）时暴露于桦树花粉（8000花粉/m³，持续120分钟）。在暴露期间每10分钟评估总症状评分（TSS）以及鼻、眼、支气管系统和其他方面的评分。其他次要终点是幸福感、峰值鼻吸气流量（PNIF）、肺功能参数的变化以及安全性。共同主要终点是两次访视中暴露120分钟后总鼻症状评分（TNSS）和TSS的差异。使用线性混合效应模型以探索性方式分析症状评分的时间演变。
27名患者（平均年龄45岁，15%为男性）完成了研究。摄入共生菌后，两个共同主要终点均显示出显著改善。在120分钟时，TNSS和TSS的中位数分别降低了50%和80%（调整后p值分别为0.025和p<0.01）。随着时间的推移，所有四个症状评分以及个人幸福感均有临床意义上的改善，在末次桦树花粉暴露的120分钟内症状的增加减弱即可看出。PNIF、呼气峰流量（PEF）和肺量计检查未观察到相关差异。两次暴露前后均无气道阻塞或肺功能受限。V3后暴露后的迟发反应减少，表明患者对桦树花粉的耐受性更好。共生食品补充剂的安全性和耐受性良好，未观察到不良事件（AE）。
首次在AEC中对桦树花粉诱发的有或无哮喘的鼻结膜炎患者进行共生食品补充剂评估，结果显示有显著有益效果，症状和幸福感显著改善，同时保持了良好的安全性和耐受性。
