Department of Microbiology, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia.
BMC Infect Dis. 2011 Apr 1;11:83. doi: 10.1186/1471-2334-11-83.
The prevalence of asthma and atopic disease has been reported to be low in low income countries, however helminth infections are likely to be high among these communities. The question of whether helminth infections play a role in allergic diseases can best be addressed by intervention studies. None of the studies so far have been based on a large scale placebo-controlled trial.
METHOD/DESIGN: This study was designed to assess how intestinal helminth infections can influence the immune response and atopic and allergic disorders in children in Indonesia. The relations between allergic outcomes and infection and lifestyle factors will be addressed. This study was set up among school-age children in semi urban and rural areas, located in Ende District of Flores Island, Indonesia. A randomized placebo-controlled anthelmintic treatment trial to elucidate the impact of helminth infections on the prevalence of skin prick test (SPT) reactivity and symptoms of allergic diseases will be performed. The children living in these semi-urban and rural areas will be assessed for SPT to allergens before and after 1 and 2 years of treatment as the primary outcome of the study; the secondary outcome is symptoms (asthma and atopic dermatitis); while the tertiary outcome is immune responses (both antibody levels to allergens and cellular immune responses).
The study will provide information on the influence of helminth infections and anthelmintic treatment on immune response, atopy and allergic disorders.
Current Controlled Trials ISRCTN: ISRCTN83830814.
据报道,低收入国家的哮喘和特应性疾病患病率较低,但这些社区的寄生虫感染率可能较高。寄生虫感染是否在过敏性疾病中起作用的问题可以通过干预研究来最好地解决。迄今为止,尚无研究基于大规模安慰剂对照试验。
方法/设计:本研究旨在评估肠道寄生虫感染如何影响印度尼西亚儿童的免疫反应以及特应性和过敏性疾病。将解决过敏结果与感染和生活方式因素之间的关系。该研究在印度尼西亚弗洛雷斯岛恩德区的半城市和农村地区的学龄儿童中进行。将进行一项随机安慰剂对照驱虫治疗试验,以阐明寄生虫感染对皮肤点刺试验(SPT)反应性和过敏性疾病症状的患病率的影响。生活在这些半城市和农村地区的儿童将在治疗前、治疗 1 年后和 2 年后进行 SPT 以评估过敏原,作为研究的主要结果;次要结果是症状(哮喘和特应性皮炎);而三级结果是免疫反应(过敏原的抗体水平和细胞免疫反应)。
该研究将提供有关寄生虫感染和驱虫治疗对免疫反应、特应性和过敏性疾病的影响的信息。
当前对照试验 ISRCTN:ISRCTN83830814。