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临床试验/NCT06947252
NCT06947252Enrolling By Invitation不适用

Validation of Food Allergies in Pediatric Atopic Dermatitis Patients Practicing Food Avoidance

Mahidol University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Frequency of food allergy among foods avoidance in atopic dermatitis children

研究概览

简要总结

Atopic dermatitis can be caused by several factors, including food allergy. Currently, the diagnosis of food allergy often performing skin tests and measuring specific IgE foods that many studies have shown that about 53% of children with atopic dermatitis have food sensitization, result in avoidance of food intake. But only 15% are confirmed to have a true food allergy, so the purpose of our study is to find the prevalence of food allergy in Thai children with atopic dermatitis who are avoiding some foods, using the oral food challenge to confirm the diagnosis to reduce unnecessary food avoidance and prevent complications from inappropriate dietary restrictions

详细描述

All subject in this study were patients with history of atopic dermatitis and avoid at least 1 food of egg yolk, egg white, cow milk, peanut, wheat or soy. All of them will undergo a blood testing for specific IgE foods to assess whether they can resume consuming that particular food or they must perform oral food challenge test in hospital to evaluate whether they truly have a food allergy or should continue to avoid that food.

The primary outcome was to study frequency of food allergy confirm by oral food challenge among foods avoidance in atopic dermatitis children, focusing on the 6 major food allergens in the Thai children: egg yolk, egg white, cow milk, peanut, wheat and soy. Other outcomes were study type of food reaction after oral food challenge test in atopic dermatitis children (IgE mediated, delayed type: AD flare)

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
— 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≤ 6 years
  • •Age ≤ 6 years with diagnosis of atopic dermatitis c
  • •Now parent report them avoid at least 1 food of egg yolk, egg white, cow milk, peanut, wheat or soy

排除标准

  • •Specific IgE food > 95%PPV (73-74%PPV in wheat, soy)
  • •Patients with uncontrolled asthma/ atopic dermatitis
  • •Patients who had been treated with some other immunotherapy e.g. SCIT, OIT
  • •Patients with delayed developmental problem or mental disorder
  • •Patient use beta-blocker, ACEI, ARB
  • •Patient who unable to follow up

研究组 & 干预措施

Atopic dermatitis children that avoid some foods

Experimental

Oral food challenge test

干预措施: Oral food challenge test (Diagnostic Test)

结局指标

主要结局

Frequency of food allergy among foods avoidance in atopic dermatitis children

时间窗: 7 days

Frequency of food allergy confirm by oral food challenge among foods avoidance in atopic dermatitis children, focusing on the 6 major food allergens in the Thai children: egg yolk, egg white, cow milk, peanut, wheat, soy

次要结局

  • Type of food reaction after oral food challenge test in atopic dermatitis children(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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