NCT01361347已完成4 期
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
详细描述
Eligibility criteria:
Age 6 - 16 yrs
- IgE-mediated milk allergy
- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms
Outcome measures:
- number of patients with successful desensitization (195 - 200 ml milk per day)
- number of patients with adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-mediated milk allergy
- •An immediately positive challenge test result to milk prior to inclusion
排除标准
- •Not willing to participate
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 12 months
次要结局
- Number of participants drinking 2 dl/day of milk (success in desensitization)(12 months)
研究者
Marita Paassilta
MD, PhD, Paediatric Allergist
Tampere University Hospital
研究点 (2)
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