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临床试验/NCT03852342
NCT03852342已完成不适用

Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
1
主要终点
Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge

研究概览

简要总结

Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge

时间窗: 1 day

An Oral Food Challenge consists in the ingestion of the suspected allergic food. The patient is given increased dose levels of this food throughout a day. The OFC is positive when the patient presents a clinical reaction (clinical symptoms linked to an allergic response) triggered by the food ingested. We'll gather the data of all patients who came in our unit of Allergology and who had a positive peanut OFC. The reactive dose is calculated from the total cumulative dose (mg) of peanut reached when the OFC peanut is considered positive. The reactive dose is considered as a time dependent data and will be analyzed with survival data analysis methods. The analyzed event is a positive OFC

次要结局

  • Time between the reaction and the last administered dose(1 day)
  • Risk factors of anaphylaxis during a positive peanut OFC(1 day)
  • Identifying risk factors of peanut hypersensitivity(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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