EPAP, Interviewstudy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Food Allergy, Food Allergy Peanut, Allergy, Anaphylactic Shock. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Survey of the Repeated Occurrence of Anaphylactic Reactions in Patients with Food Allergies
Overview
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.
Detailed description
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.
Primary outcome measures
- Frequency of allergic reactions in tree nut and peanut allergic patients within the observation period of the study [Time frame: 2 years]
Secondary outcome measures (6)
- Frequency of allergic reactions among patients with different food allergens within the observation period of the study [Time frame: 2 years]
- The association of food allergy related quality of life, measured via the Food Allergy Quality of Life Questionnaire, with repetitive allergic reactions [Time frame: 2 years]
- The association of eating habits (e.g. frequency of eating out) and the occurrence of repetitive allergic reactions [Time frame: 2 years]
- Use of emergency medication during a repetitive reaction [Time frame: 2 years]
- Use of adrenaline as first line treatment [Time frame: 2 years]
- The association of dietary counselling and successful allergen avoidance [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- if inclusion criteria are fulfilled there are no further exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT06192914 · EPAP · EA2/137/21