Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Skin Prick Tests evaluation
研究概览
简要总结
The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 6
- •Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)
排除标准
- •Pregnancy, or patients breast-feeding
- •Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
- •Patients presenting with dermographism
- •Patients not fluent in French
研究组 & 干预措施
Hyponut
干预措施: Hyponut (Other)
结局指标
主要结局
Skin Prick Tests evaluation
时间窗: day patient enrolled
次要结局
- Oral food challenge evaluation(day patient enrolled)