EPAP, Interviewstudy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
if inclusion criteria are fulfilled there are no further exclusion criteria
Trial population
The study population consists of patients (age 18 years or older) or their parents (patients age 0-17 years). Eligible patients have suffered at least one 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) within 12 months prior to presentation in a specialised food allergy center that is participating in the European Anaphylaxis Registry and in addition the EPAP follow-up project. If the patient or their parents agree to participate in the European Anaphylaxis Registry and fulfill the other inclusion criteria, they can also participate in the follow up study. We aim to include 322 patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
322 Participants
are grouped into 1 trial groupGroup A: Food Anaphylaxis Patients
Trial outcomes
Primary outcomes
1
Frequency of allergic reactions in tree nut and peanut allergic patients within the observation period of the study
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
Time frame
2 yearsSecondary outcomes
1
Frequency of allergic reactions among patients with different food allergens within the observation period of the study
The aim is to identify whether the frequency of allergic reactions after the identification of the elicitor of the initial allergic reaction differs between different food allergens
Time frame
2 years2
The association of food allergy related quality of life, measured via the Food Allergy Quality of Life Questionnaire, with repetitive allergic reactions
An anaphylactic reaction to food can impact quality of life. The investigators want to observe the food allergy related quality of life over the study period and examine whether the existence of repetitive reaction influences quality of life. Food allergy related quality of life is measured via the Food Allergy Quality of Life Questionnaire (FAQLQ). Patients can achieve 1 - 7 points, where a higher score represents a higher impairment of quality of life and 1 point represents no impairment.
Time frame
2 years3
The association of eating habits (e.g. frequency of eating out) and the occurrence of repetitive allergic reactions
An anaphylactic reaction to food can influence eating habits and specific eating habits can be related to more frequent accidental allergic reactions. The investigators want to observe whether the eating habits differ between patients with and without recurrent allergic reactions. The eating habits are captured with a non-validated questionnaire. Patient are requested to answer, whether they follow a specific diet (e.g. vegan, vegetarian, religious diets) and how often they use specific ways of eating out (e.g. in a restaurant or eating at a friends place). The eating habits are captured at every time point of the study (baseline, 3, 6, 12, 24 months).
Time frame
2 years4
Use of emergency medication during a repetitive reaction
The prescripton of emergency medications and the instruction about their use enables patients or their relatives to take care of the primary treatment of anaphylactic reactions. The investigators want to compare whether the use of emergency medication during subsequent anaphylactic reactions increases. Patients are requested to provide details about the use of emergency medication for each allergic reaction they report via the study period.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov