Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
研究概览
简要总结
This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.
详细描述
Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children's Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
- cookies, max 30 g;
- chocolate, max 30 g;
- breakfast cereals, max 50 g.
Each meal will be administered with a 1 hour observation period in between and at the end.
If the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).
An age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 2-18 years at time of inclusion
- •Tree nut or peanut allergy documented by:
- •Positive skin prick tests (SPTs) to peanut and/or tree nuts
- •Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)
- •A recent (< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.
- •Parent/Legal guardian has been informed about the study and has signed Informed Consent Form
排除标准
- •History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.
- •Expected non-adherence to the study protocol.
- •Severe or uncontrolled asthma.
结局指标
主要结局
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
时间窗: At study entry
Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).
次要结局
- Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
- Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
- Changes of quality of life after 3 months without restriction of foods labelled with "may contain traces", compared to baseline when restricting.(At entry and after 3 months)
- Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.(During 3 months follow-up)
研究者
Philippe Eigenmann
Head, Pediatric Allergy Unit, Department of Pediatrics
University Hospital, Geneva