The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- the outbreaks of atopic skin
研究概览
简要总结
To assess the efficacy and safety of the use of probiotics as food supplements in reducing the SCORAD index in children with atopic skin compared with placebo. This is a randomized, placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. Patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05) and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
- •Patients aged 2-14 years.
排除标准
- •Patients intolerant to gluten, lactose or cow's milk protein.
- •Patients who change the type of diet during the study to improve their atopic dermatitis.
- •Patients with atopic dermatitis in remission phase (absence of sprouts and with SCORAD index = 0).
- •Patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study.
- •Patients taking immunomodulators, topical or oral antibiotics, topical or oral antihistamines, oral corticosteroids or antineoplastics.
- •Subjects whose condition does not make them eligible for the study, according to the investigator.
结局指标
主要结局
the outbreaks of atopic skin
时间窗: 12 weeks
use the SCORAD index to measure the outbreaks of atopic skin
次要结局
未报告次要终点