NCT00200928已完成不适用
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
The Netherlands Asthma Foundation2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 1999年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence and severity of atopic disease.
研究概览
简要总结
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
详细描述
A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.
Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease.
Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
排除标准
- •maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)
结局指标
主要结局
Incidence and severity of atopic disease.
次要结局
- SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
研究者
研究点 (2)
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