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临床试验/NCT04318483
NCT04318483已完成不适用

Clinical and Biological Description of an Atypical IgE-mediated Cow Milk Allergy (CMA) Form With Hands and Feet Angio-oedema From the Diagnosis to Its Spontaneous Evolution and Comparison to the Typical CMA Form Without Oedema of Extremities

Fondation Lenval0 个研究点目标入组 121 人开始时间: 2020年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
主要终点
kinetics of specific IgE

研究概览

简要总结

Cow milk allergy is one of the most frequent food allergy among children. Cow milk protein's avoidance is needed until spontaneous recovery during the two first years of life. A atypical clinical form with angio-oedema of hands and feet which is associated with high rate of lactoserum's IgE might be a hope of an earlier recovery.

详细描述

Cow Milk allergy is one of the most frequent pediatric food allergy and occurs during the first months of life. It is due to an inappropriate reaction of immune system against the human body. Its treatment is the avoidance of the cow milk proteins. Its spontaneous recovery occurs mostly during the first years of life with the decreasing of the specific IgE and the clinical tolerance to cow milk proteins.

Two shorts cas reports (3 and 5 patients) have described a clinical form of IgE-mediated cow milk allergy with angio-oedema of hands and feet. This clinical form is associated with more increasing of specific IgE against lactoserum proteins than caseine's. However it has been showed that casein is a marker of cow milk allergy persistence. It might be possible that this atypical form of cow milk allergy progresses favorably towards a restoration of tolerance earlier than the clinical form without angio-oedema of the extremities

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with a concordant history of IgE-mediated CMA (skin reaction within the next hours of cow milk proteins intake, regression of symptoms with avoidance of cow milk, +/- recurrence of identical symptoms when readministration)
  • Patients with documented positive awareness markers (skin test and/or specific IgE > 0,1 kilo units of allergen-specific IgE per liter (kUA/l ))
  • Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice

排除标准

  • patients without IgE specific performed in the first month after the reaction
  • patients who have had only 1 documented specific IgE test

结局指标

主要结局

kinetics of specific IgE

时间窗: at inclusion

kinetic is defined by dosage of specific IgE (cow milk, caseine, whey proteins) from diagnostic from control to 7 months after

次要结局

  • Clinical characteristics of allergic reaction(at inclusion)
  • Clinical characteristics of patients(at inclusion)
  • Age of clinical tolerance(at inclusion)
  • comparison of specific IgE kinetics between case and control patient(at inclusion)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

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