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临床试验/NCT01164293
NCT01164293已完成1 期

Prevalence of Positive Reactions in Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms

Mahidol University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年4月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms

研究概览

简要总结

Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms

详细描述

The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:

(i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

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 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food.
  • Age 1 month-18 yrs
  • Elimination diet was done at least 7 days before starting the study
  • Written informed consent was obtained from the parents of each child enrolled in the study

排除标准

  • Who have dermographism
  • Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
  • Pregnant women
  • Who have severe eczema
  • Who receive antihistamine, topical steroid and systemic steroid > 20 mg/day withiin 7 days prior study

研究组 & 干预措施

Atopy patch test

Experimental

Atopy patches were applied on food allergy patient's back for 48 hrs then the patches were removed. Reaction was evaluated at 48 and 72 hrs after applying atopy patch test

干预措施: Atopy patch test with food allergen (Device)

结局指标

主要结局

Prevalence of positive reaction in APT in children with food allergy-related gastrointestinal symptoms

时间窗: 3 days

To evaluate (i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test.

次要结局

  • Comparisons atopy patch test reaction between lyophilized allergen and commercial allergen(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nualanong Visitsunthorn

Professor

Mahidol University

研究点 (2)

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