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临床试验/NCT01776489
NCT01776489Unknown不适用

The Role of Sphingosine-1-phosphate in Food Allergy - Biomarker for Disease Severity and Anaphylaxis Outcome

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
S1P in allergic and non-allergic patients before and after challenge

研究概览

简要总结

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date.

Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).

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
12 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to DBPCFC or open provocation
  • Patients who are diagnosed by elevated allergen specific IgE and/or positive skin prick testing
  • Willingness to participate in the study

排除标准

  • Refusal to participate in the study
  • Non-IgE-mediated food allergy

结局指标

主要结局

S1P in allergic and non-allergic patients before and after challenge

时间窗: up to 3 years

The primary endpoint of this study is the measurement of S1P in allergic and non-allergic patients before and after challenge.

次要结局

  • Evaluation of allergic mediators and correlation with S1P levels(up to 3 years)

研究者

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

Eva Untersmayr-Elsenhuber

Assoc. Prof., Dr.

Medical University of Vienna

研究点 (1)

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