NCT03059589已完成不适用
National Registry of Food Allergy Treatment
Food Allergy Support Team1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2017年4月15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
- 2,000
- 试验地点
- 1
- 主要终点
- efficacy of food allergy treatment
研究概览
简要总结
The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.
详细描述
Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
- •no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food
排除标准
- •pregnancy
- •severe asthma
- •poorly controlled atopic dermatitis
- •eosinophilic esophagitis
结局指标
主要结局
efficacy of food allergy treatment
时间窗: 3 years
the percentage of patients who successfully reach the maintenance dose of food
次要结局
- epinephrine use(3 years)
- factors associated with the failure to reach the target dose of food ingestion(3 years)
研究者
研究点 (1)
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