Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Tolerance for each ingested dose is assessed by a clinical score
研究概览
简要总结
Reintroduction of small doses of food in allergic children to lightening the elimination diet.
详细描述
In four groups of allergic children (peanuts, wheat , milk and egg), a reintroduction of 4 small increasing doses of allergen is carried out progressively double-blind placebo- cons , randomized, during a hospitalization.
The procedure for reintroduction of small doses (MPD) is stopped at the appearance of intolerance (in taking a dose of allergen or placebo) defined by the onset of allergic symptoms or objective severe abdominal pain within 45 minutes of taking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic children 1 and 16 years for peanut, egg and wheat. So, for milk between 9 months and 16 years.
- •Accurate diagnostic
- •Allergic react rapidly and acute
排除标准
- •severe disease
研究组 & 干预措施
allergic food
Reintroduction procedure for small doses :
- Administration of the first dose the first dose must be allergic food or placebo
- Clinical monitoring for 45 minutes
- Administration of the second dose
干预措施: allegic food (Other)
allergic food
Reintroduction procedure for small doses :
- Administration of the first dose the first dose must be allergic food or placebo
- Clinical monitoring for 45 minutes
- Administration of the second dose
干预措施: Placebo (Other)
结局指标
主要结局
Tolerance for each ingested dose is assessed by a clinical score
时间窗: 45 minutes
Tolerance is defined by the absence of allergy symptoms within 45 minutes of ingestion of the allergen dose in the absence of intolerance to previous placebo
次要结局
未报告次要终点