EPAP, Interviewstudy

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.

Study Overview

• Status: Recruiting
• Conditions: Allergy; Food Allergy; Food Allergy Peanut; Anaphylactic Shock

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.

• Study Type: Observational
• Enrollment (Estimated): 322

Contacts and Locations

• Study Contact: Name: Margitta Worm, MD; Phone Number: +49 30 450 518 105; Email: sekreteriat-worm@charite.de
• Study Contact Backup: Name: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518 367; Email: sabine.doelle@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518 367; Email: sabine.doelle@charite.de
    • Contact: Margitta Worm, MD; Phone Number: +49 30 450 518 105; Email: sekretariat-worm@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Food Anaphylaxis Patients; Patients with anaphylaxis to legumes, tree nuts, seeds, cereals and pseudocereals within the last 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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).	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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Margitta Worm, MD, Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Food Allergy; Repetitive Reactions
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: EPAP; EA2/137/21 (Other Identifier: local ethic committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No