EPAP, Interviewstudy

NCT06192914 | Recruiting

• 2 other identifiers: EPAPEA2/137/21
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy; Food Allergy Peanut; Allergy; Anaphylactic Shock

Keywords

Food Allergy; Repetitive Reactions; Quality of Life

Outcome Measures

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

  2 years

Secondary Outcomes (6)

• 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

• Use of emergency medication during a repetitive reaction

  2 years

• Use of adrenaline as first line treatment

  2 years

Study Arms (1)

Food Anaphylaxis Patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Margitta Worm, MD

  Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margitta Worm, MD

CONTACT

+49 30 450 518 105; sekreteriat-worm@charite.de

Sabine Dölle-Bierke, PhD

CONTACT

+49 30 450 518 367; sabine.doelle@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: March 1, 2022
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)