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临床试验/NCT01801748
NCT01801748已完成不适用

The Natural History of Wheat Hypersensitivity in Thai Children

Mahidol University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
The number of participants who outgrow from wheat allergy

研究概览

简要总结

Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.

详细描述

All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing. The primary outcome was the development of oral tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Year 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children 1 to 15 years
  • History of IgE-mediated wheat allergy

排除标准

  • Parents refused to sign the consent
  • Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.

结局指标

主要结局

The number of participants who outgrow from wheat allergy

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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