Cao Xueqiu, Zhong Ping, Li Gang, Zhu Jiao, Zheng Yun
Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu.
Department of Otorhinolaryngology-Head and Neck Surgery, Minda Hospital of Hubei Minzu University, Enshi, China.
Medicine (Baltimore). 2020 May;99(18):e20095. doi: 10.1097/MD.0000000000020095.
Several studies have suggested that intestinal flora may play an important role in allergic diseases. The purpose of this study was to investigate the effect of probiotics of Bifidobacterium triplex on the symptoms of allergic rhinitis (AR). The effects of this probiotic on the immune system have been reported in some studies, but most previous studies have been in animals.
METHODS/DESIGN: 60 infants and young children with AR were randomly divided into 2 groups: probiotics/placebo group. The main outcome was the use of a comprehensive symptom drug score to assess allergy symptoms. In addition, health-related quality of life was investigated (rhinitis quality of life questionnaire). Secondary outcomes included a visual analog scale of allergy burden and a second quality of life questionnaire. This report describes the study design of a randomized controlled trial.
The study design described a double-center, randomized, location at the Minda Hospital of Hubei Minzu University and West China Hospital of Sichuan University, which will be focused on the study about probiotics treatment and its effect on AR symptoms.
It has been registered at http://www.chictr.org.cn/listbycreater.aspx (Identifier: ChiCTR2000031175), Registered March 22, 2020.
多项研究表明肠道菌群可能在过敏性疾病中发挥重要作用。本研究旨在探讨三联双歧杆菌益生菌对过敏性鼻炎(AR)症状的影响。一些研究报道了这种益生菌对免疫系统的作用,但此前大多数研究都是在动物身上进行的。
方法/设计:60例AR婴幼儿被随机分为2组:益生菌/安慰剂组。主要结局是使用综合症状药物评分来评估过敏症状。此外,还调查了健康相关生活质量(鼻炎生活质量问卷)。次要结局包括过敏负担视觉模拟量表和第二份生活质量问卷。本报告描述了一项随机对照试验的研究设计。
该研究设计为双中心、随机化,地点在湖北民族大学附属民大医院和四川大学华西医院,将聚焦于益生菌治疗及其对AR症状影响的研究。
已在http://www.chictr.org.cn/listbycreater.aspx注册(标识符:ChiCTR2000031175),于2020年3月22日注册。