Department Naturwissenschaften, Medical School Berlin, Berlin, Germany
Department of Internal Medicine VI: Psychosomatic Medicine and Psychotherapy, University of Tubingen, Tübingen, Germany.
BMJ Open. 2019 Oct 28;9(10):e031339. doi: 10.1136/bmjopen-2019-031339.
Several studies suggest that gut microbiota may play an important role in allergic diseases. The present trial aims to examine effects of the probiotic on symptoms of allergic rhinitis in patients. Effects of this probiotic on the immune system have been reported by several studies, but the majority of the previous trials were animal studies. In addition, it is well known that symptoms in allergic rhinitis are prone to exhibit high placebo responses. Moreover, recent studies report that even placebos without deception (open-label placebos) are highly effective in reducing symptoms of allergic rhinitis. Our study design combines both new approaches to assess effects on allergic symptoms in patients. The objective of this study is to compare the effects of a probiotic treatment () with effects seen by open-label placebo, concealed placebo treatment and no treatment control.
A total of 120 patients with allergic rhinitis will be randomly assigned to one of four different groups: a double-blind probiotic/placebo group (groups 1 and 2), an open-label placebo group (group 3) and a no-treatment group (group 4) to control for spontaneous variation of symptoms. The primary outcome is the evaluation of allergic symptoms using the Combined Symptoms Medication Score. Furthermore, health-related quality of life is examined (Rhinitis Quality of Life Questionnaire). Secondary outcomes include a visual analogue scale on allergic burden and a second quality of life questionnaire. This report describes the study design of the randomised controlled trial.
The study design was approved by the ethical committee of the UKT Department of Psychosomatic Medicine and Psychotherapy, Tübingen, Germany. The trial is registered at the German Clinical Trials Register (www.drks.de, DRKS00015804). The trial results will be published in peer-reviewed journals and at conferences.
German Clinical Trials Register (www.drks.de, DRKS00015804); Pre-results.
多项研究表明，肠道微生物群可能在过敏疾病中发挥重要作用。本试验旨在研究益生菌对过敏性鼻炎患者症状的影响。几项研究报告了这种益生菌对免疫系统的影响，但以前的大多数试验都是动物研究。此外，众所周知，过敏性鼻炎的症状容易出现高安慰剂反应。此外，最近的研究报告称，即使是没有欺骗（开放标签安慰剂）的安慰剂也能非常有效地减轻过敏性鼻炎的症状。我们的研究设计结合了评估患者过敏症状的新方法。本研究的目的是比较益生菌治疗（）与开放标签安慰剂、隐蔽安慰剂治疗和无治疗对照组的效果。
共 120 名过敏性鼻炎患者将被随机分配到四个不同的组之一：双盲益生菌/安慰剂组（第 1 组和第 2 组）、开放标签安慰剂组（第 3 组）和无治疗组（第 4 组），以控制症状的自发变化。主要结局是使用综合症状药物评分评估过敏症状。此外，还检查了健康相关的生活质量（鼻炎生活质量问卷）。次要结局包括过敏负担的视觉模拟量表和第二个生活质量问卷。本报告描述了随机对照试验的研究设计。
该研究设计得到了德国图宾根 UKT 身心医学和心理治疗系伦理委员会的批准。该试验在德国临床试验注册处（www.drks.de，DRKS00015804）注册。试验结果将发表在同行评议的期刊和会议上。
德国临床试验注册处（www.drks.de，DRKS00015804）；预结果。
