NCT01633840已完成不适用
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges
Christina West1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2008年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials
研究概览
简要总结
This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children belonging to one of two age groups: 7-8 years or 14-15 years
- •No previous hypersensitivity reaction to the food to be tested
- •Capacity to understand the test instructions and to participate in the test sessions
排除标准
- •Children not belonging to one of the two age groups: 7-8 years or 14-15 years
- •One or more previous hypersensitivity reaction to the food to be tested
- •Unability to understand the test instructions and to participate in the test sessions
研究组 & 干预措施
Elemental E028 with added food allergens
Active Comparator
干预措施: Elemental E028 with added food allergens (Other)
Elemental E028
Placebo Comparator
干预措施: Elemental E028 (Other)
结局指标
主要结局
Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials
The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by assessing that no sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials could be detected by test panels.
次要结局
未报告次要终点
研究者
Christina West
MD, PhD
Umeå University
研究点 (1)
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