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Active, not recruitingNCT06192914Updated Oct 22, 2026

EPAP, Interviewstudy

An observational study in Food Allergy, Food Allergy Peanut and Allergy, sponsored by Charite University, Berlin, Germany. Active, not recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-10-22.

Primary conditionPeanut HypersensitivityRegistry: Food HypersensitivityReclassifiedWhy we changed it
Registry
Food Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Peanut Hypersensitivity
Why
  1. The study's listed conditions name Peanut Hypersensitivity, a narrower term within Food Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Charite University, Berlin, Germany · Observational

Updated Oct 22, 2026Now Active, not recruiting1 site added+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
322
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Food Allergy
  • Food Allergy Peanut
  • Allergy
  • Anaphylactic Shock

Browse trials for

Keywords

  • Food Allergy
  • Repetitive Reactions
  • Quality of Life
03

In context

Peanut Hypersensitivity Reclassified

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's planned enrollment of 322 is above the median of 220 across 30 observational studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Compared within Peanut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • if inclusion criteria are fulfilled there are no further exclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
322 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Food Anaphylaxis Patients

    Patients with anaphylaxis to legumes, tree nuts, seeds, cereals and pseudocereals within the last 12 months

06

What researchers measure

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 years

Secondary 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 years

  2. 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 years

  3. 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 years

  4. 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 years

  5. 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.

    Time frame: 2 years

  6. 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.

    Time frame: 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Feb 2029, 83 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2023
First posted
Jan 5, 2024
StartActual
Mar 1, 2022
Primary completionEst.
Feb 28, 2029
CompletionEst.
Feb 28, 2029
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 22, 2026
Sites
1 site added, 1 site removed
Show site
  • Charité - Universitätsmedizin Berlin · Berlin, Germany
Show 1 removed
  • Charité - Universitätsmedizin Berlin · Berlin, Germany
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Active, not recruiting
    1 site added, 1 site removed
    Show site
    • Charité - Universitätsmedizin Berlin · Berlin, Germany
    Show 1 removed
    • Charité - Universitätsmedizin Berlin · Berlin, Germany
    + 5 other changes: identifiers, verification date, oversight details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06192914
Responsible party
Margitta Worm (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 5, 2024
Start date
Mar 1, 2022
Primary completion
Feb 28, 2029 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

Margitta Worm, MD
principal investigator · Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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