Prospective Survey of the Repeated Occurrence of Anaphylactic Reactions in Patients with Food Allergies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- Frequency of allergic reactions in tree nut and peanut allergic patients within the observation period of the study
研究概览
简要总结
The goal of this observational study is to learn about repetitive anaphylactic reactions in food allergic patients and to compare the frequency of repetitive reactions between different elicitors in food allergic patients. The main question it aims to answer are:
• Is there an elicitor specific difference in the occurrence of anaphylactic reactions once the elicitor has been identified and the patient received counselling about its avoidance?
Participants will answer questionnaires via a link they will receive via e-mail at baseline and 3, 6, 12 and 24 months after inclusion in the study.
详细描述
The aim of the study is to establish a cohort of patients who were included in the anaphylaxis registry with an anaphylactic reaction to legumes, tree nuts, seeds, grains or pseudocereals within the previous twelve months. Patients are requested to provide information about the occurrence of new allergic reactions at defined time-points over a period of two years (at baseline, 3, 6, 12, and 24 months). In addition, their eating behavior and the food allergy-specific quality of life will be captured. The investigators intend to track self-management in dealing with anaphylaxis, especially the use of emergency medication. It is examined whether patients react again and whether these are reactions to a known or previously unknown allergen to the patient. By recording the symptoms, it will be checked whether there are certain reaction patterns to specific foods or whether these are patient specific. In addition, the influence of the previous anaphylactic reaction and knowledge of the existing allergy on quality of life, dietary behavior and the ability to use emergency medication should be examined.
This is intended to help improve the care for future patients in order to minimize the risk of repeat reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anaphylactic reaction to peanuts, other legumes, tree nuts, seeds (e.g. sesame seed, sunflower seed), cereals (e.g. wheat, oat) or pseudocereals (e.g. quinoa)
- •participation in the European Anaphylaxis Registry (Clinical Trials Identifier: NCT05210543)
- •possibility and consent to receive links to the follow-up electronic surveys via e-mail and fill out the questionnaires electronically
排除标准
- •if inclusion criteria are fulfilled there are no further exclusion criteria
结局指标
主要结局
Frequency of allergic reactions in tree nut and peanut allergic patients within the observation period of the study
时间窗: 2 years
The aim is to identify whether the frequency of allergic reactions after the identification of the elicitor of the initial allergic reaction differs between peanuts and tree nuts
次要结局
- Use of emergency medication during a repetitive reaction(2 years)
- Use of adrenaline as first line treatment(2 years)
- Frequency of allergic reactions among patients with different food allergens within the observation period of the study(2 years)
- The association of food allergy related quality of life, measured via the Food Allergy Quality of Life Questionnaire, with repetitive allergic reactions(2 years)
- The association of eating habits (e.g. frequency of eating out) and the occurrence of repetitive allergic reactions(2 years)
- The association of dietary counselling and successful allergen avoidance(2 years)
研究者
Margitta Worm
Prof. Dr.
Charite University, Berlin, Germany