Food AllergyNCT06192914
EPAP, Interviewstudy
An observational study of Food Allergy and Food Allergy Peanut, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergy, Food Allergy Peanut, Allergy
- How many people
- 322 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2022to 28 Feb 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- if inclusion criteria are fulfilled there are no further exclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Prospective Survey of the Repeated Occurrence of Anaphylactic Reactions in Patients With Food Allergies
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.
Read the 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.
- Conditions
- Food Allergy, Food Allergy Peanut, Allergy, Anaphylactic Shock
- Keywords
- Food Allergy, Repetitive Reactions, Quality of Life
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food Anaphylaxis Patients | Patients with anaphylaxis to legumes, tree nuts, seeds, cereals and pseudocereals within the last 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
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
Measured: 2 years
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.
Measured: 2 years
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).
Measured: 2 years
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.
Measured: 2 years
Use of adrenaline as first line treatment
The instruction about adrenaline autoinjectors and their use as first line treatment in case of an allergic reaction increases the frequency of its use. The investigators want to compare whether the use of adrenaline as a first line treatment during subsequent anaphylactic reactions increases. Patients are requested to provide details about the use of adrenaline for each allergic reaction they report via the study period.
Measured: 2 years
The association of dietary counselling and successful allergen avoidance
The investigators hypothesize that dietary counselling enables patients to avoid their allergen effectively and reduces the number of allergic reactions compared to the time before dietary counselling. Patients are requested to provide the number of allergic reactions throughout the two years before inclusion in the study in the baseline questionnaire. This number will be compared with the number of reactions patients report during the study. The study inclusion always takes place in a specialized allergy center, where every patient receives counselling about allergen avoidance.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Mar 2022
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 322 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Margitta Worm, MD, Principal investigator, Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192914
- Sponsor's protocol ID
- EPAP
- Other IDs
- EA2/137/21
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No