NCT01526863已完成不适用
Assessment of the Effect of an HA Egg Administration for 6 Months on the Tolerance Induction to Egg in Children Allergic to Egg as Compared to a Placebo
Société des Produits Nestlé (SPN)6 个研究点 分布在 3 个国家目标入组 29 人开始时间: 2012年10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
- 29
- 试验地点
- 6
- 主要终点
- positive or negative result (objective and subjective symptoms) of a challenge test with egg
研究概览
简要总结
The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child of any ethnicity aged between 12 and 66 months at the time of enrolment
- •Positive Skin Prick Test (SPT) to egg white within the last 3 months
- •Either positive oral challenge OR convincing history, defined as an immediate (<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months
- •Having obtained his/her signed legal representative's informed consent.
排除标准
- •History of severe anaphylaxis to egg
- •Significant pre-natal and/or post-natal disease
- •Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment
- •Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- •Child whose parents / caregivers cannot be expected to comply with treatment
- •Child currently participating in another interventional clinical trial
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: HA egg (Dietary Supplement)
HA egg
Active Comparator
干预措施: HA egg (Dietary Supplement)
结局指标
主要结局
positive or negative result (objective and subjective symptoms) of a challenge test with egg
时间窗: 6 months
次要结局
- Immunological parameters: total and specific IgE and IgG4, cytokines, basophil activation(6 months)
- skin prick test (sensitization to egg; size of wheal and flare)(6 months)
- compliance (product taken)(6 months)
- Morbidity / Adverse Events(6 months)
研究者
研究点 (6)
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