Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SCORAD
研究概览
简要总结
Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.
Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta [TGF - β]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Atopic Dermatitis
- •Children over 6 months.
- •Teens lower than 19 years
- •No inclusion /
排除标准
- •Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
- •Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
- •Allergy or severe adverse reactions attributable to the administration of the probiotic.
- •Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.
- •Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.
- •Patient's request (or responsible's request)
研究组 & 干预措施
Probiatop
Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months
干预措施: Probiatop (Drug)
Placebo
Placebo of Maltodextrin in sachet
干预措施: Placebo (Drug)
结局指标
主要结局
SCORAD
时间窗: 1 year
Change from baseline in SCORAD every 3 months for 1 year
次要结局
- Inflammation composite(1 year)
- Immune tolerance composite(1 year)
- Total serum IgE(1 year)
- Skin prick test (immediate awareness)(1 year)
研究者
Fabio Carmona
University of Sao Paulo
Casa Espirita Terra de Ismael