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临床试验/NCT00356174
NCT00356174已完成不适用

A Prospective Cohort Study of Immune Mechanisms, Genetic Factors, and Clinical and Environmental Characteristics Associated With the Occurrence and Clinical Outcome of Food Allergy (CoFAR2)

National Institute of Allergy and Infectious Diseases (NIAID)5 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2006年7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
515
试验地点
5
主要终点
Peanut allergy after the age of three years

研究概览

简要总结

The purpose of this study is to observe the natural course of food allergy, including both the development of peanut allergy in infants at high risk for developing this allergy, and the resolution of both egg and cow's milk allergy.

详细描述

This observational study will investigate the developmental immunology of peanut, egg, and milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut allergy. This strategy will help to delineate, compare, and contrast biological markers and immunologic changes associated with the development of peanut allergy and loss of egg and milk allergy, while simultaneously evaluating important clinical and environmental influences likely to account for the recent rise in the prevalence of these allergies. The hallmark of food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies that represent an end result of a T helper 2 (Th2) influenced immune response. Currently, there is only a limited understanding of the mechanisms involved in the developmental course of food allergies. To effectively prevent or reverse the progression of food allergy, immune interventions will be needed. Furthermore, it is likely that successful strategies will need to be directed to those persons at identifiable risk (e.g., who have biomarkers associated with development of peanut allergy).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Peanut allergy after the age of three years

时间窗: Year 10

diagnosed by generally accepted, \> 95% accurate, clinical criteria such as oral food challenge.

次要结局

  • Resolution of peanut allergy after the age of three years(Year 10)
  • Resolution of milk allergy after the age of three years(Year 10)
  • Resolution of egg allergy after the age of three years(Year 10)
  • Resolution of a positive test to peanut after the age of three years (suspected allergy category)(Year 10)
  • Development/persistence of milk allergy after the age of three years(Year 10)
  • Development/persistence of egg allergy(Year 10)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (5)

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