EPAP, Interviewstudy

NCT ID: NCT06192914

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 322 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2029-02-28

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Food Anaphylaxis Patients

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

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Margitta Worm

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margitta Worm, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Margitta Worm, MD

Role: CONTACT

sekreteriat-worm@charite.de

+49 30 450 518 105

Sabine Dölle-Bierke, PhD

Role: CONTACT

sabine.doelle@charite.de

+49 30 450 518 367

Facility Contacts

Margitta Worm, MD

Role: primary

sekretariat-worm@charite.de

+49 30 450 518 105

Sabine Dölle-Bierke, PhD

Role: backup

sabine.doelle@charite.de

+49 30 450 518 367

Other Identifiers

EA2/137/21

Identifier Type: OTHER

Identifier Source: secondary_id

EPAP

Identifier Type: -

Identifier Source: org_study_id