Evaluation of the Effects of a Combination of Probiotics in the Treatment of Adult Atopic Dermatitis: Randomized Phase III, Double-blind Placebo-controlled
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- clinical effects of probiotics on adult atopic dermatitis
研究概览
简要总结
Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and prevention but their precise role is not yet clear.
The aim of this randomized double blinded active treatment vs placebo study was to evaluate clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01 and Bifidobacterium breve BR03) for the treatment of adult AD patients.
The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to some experimental hypotheses:
- The use of these microbial agents at an early age seems to play an important role in inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE mediated
- the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance
- the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-55 years between
- •Diagnosis of DA moderate and / or severe, as assessed by the use of a standardized index of severity of AD (SCORAD = Scoring Atopic Dermatitis index) (42), prepared by the European Task Force for atopic dermatitis
排除标准
- •Allergic contact dermatitis (ACD), active
- •In the absence of known food allergy elimination diet
- •Chronic diseases (autoimmune diseases, COPD, heart disease, IRC, CNS disease, chronic gastrointestinal diseases, diabetes, congenital or acquired immunosuppression)
- •Pregnancy and / or lactation
- •Treatment with probiotics in the 6 months preceding enrollment
- •Treatment with steroids and antihistamines systemically in the three months prior to enrollment
- •Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment
- •Acute or chronic infectious diseases
- •Pre-existing hypersensitivity to components contained in the probiotic
结局指标
主要结局
clinical effects of probiotics on adult atopic dermatitis
时间窗: 20 weeks
To evaluate the clinical course of adult patients affected by atopic dermatitis after the intake of two probiotics vs placebo
次要结局
- effects of probiotics on immune system and faecal microbiota in adult atopic dermatitis(20 weeks)
研究者
Iemoli Enrico
head allergy and clinical immunology departement
ASST Fatebenefratelli Sacco