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临床试验/NCT04013763
NCT04013763终止不适用

Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care

Mahidol University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年7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
终止
入组人数
7
试验地点
1
主要终点
Specific IgE to wheat and omega-5 gliadin level

研究概览

简要总结

Wheat allergy is increasing in Thailand. Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.

详细描述

All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not). Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin. Transepidermal water loss was examined in case with atopic dermatitis. The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •children age 1 to 18 years
  • •History of IgE-mediated wheat allergy

排除标准

  • •Parents refused to sign the consent
  • •severe atopic dermatitis
  • •on oral immunothery
  • •severe IgE mediated reaction after using wheat containing skin care product

研究组 & 干预措施

Atopic dermatitis with stop using product

Experimental

case wheat allergy with atopic dermatitis and stop using wheat containing skin care products

干预措施: wheat containing skin care products (Other)

Atopic dermatitis with containing using product

Experimental

case wheat allergy with atopic dermatitis and continue using wheat containing skin care products

干预措施: wheat containing skin care products (Other)

Non atopic dermatitis with stop using product

Experimental

case wheat allergy with normal skin and stop using wheat containing skin care products

干预措施: wheat containing skin care products (Other)

Non atopic dermatitis with continue using product

Experimental

case wheat allergy with normal skin and continue using wheat containing skin care products

干预措施: wheat containing skin care products (Other)

Atopic dermatitis with no product use

No Intervention

case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis

Non atopic dermatitis with no product use

No Intervention

case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis

结局指标

主要结局

Specific IgE to wheat and omega-5 gliadin level

时间窗: 1 year

To follow-up the level of wheat and omega5 gliadin specificIgE after stop using the wheat containing skin care product compare to patients who continue using the product.

次要结局

  • level of transepidermal water loss(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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