A Double Blind, Randomized, Placebo-Controlled, Crossover Study to Compare the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy in Korean Infants
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 36
- 主要终点
- Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
研究概览
简要总结
There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.
The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under the 2 years old, 36 children
- •Mild to moderate atopic dermatitis with cow milk allergy
- •Volunteers who agreed by their parents.
- •The severity of their disease was assessed by modified SCORAD index
排除标准
- •Severe atopic dermatitis
- •Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks
- •Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk
- •Chronic diarrhea
研究组 & 干预措施
Group A
Group A received active medication (ATP mixed probiotics) for 6 weeks followed by a crossover to 6 weeks of placebo after 4-weeks washout period.
干预措施: ATP mixed probiotics (Drug)
Group B
Group B received placebo medication for 6 weeks followed by a crossover to 6 weeks of active medication (ATP mixed probiotics) after 4-weeks washout period.
干预措施: Placebo (Drug)
结局指标
主要结局
Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration
时间窗: 6 weeks after patient recruitment
次要结局
- Check SCORAD index for severity of atopic dermatitis, symptom diary, blood cytokine and chemokine (IL-4,IL-6, IL-10, IL-13, total IgE, IFN-γ, TGF-β, TNF-α, and IgG4) after drug administration(6 weeks after wash-out period)