Идёт набор NCT06192914

EPAP, Interviewstudy

— Наблюдательное Food Allergy Food Allergy Peanut Allergy Anaphylactic Shock

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Food Allergy, Food Allergy Peanut, Allergy, Anaphylactic Shock. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Survey of the Repeated Occurrence of Anaphylactic Reactions in Patients with Food Allergies

Обзор

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.

Подробное описание

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.

Первичные конечные точки

Frequency of allergic reactions in tree nut and peanut allergic patients within the observation period of the study [Срок оценки: 2 years]

Вторичные конечные точки (6)

Frequency of allergic reactions among patients with different food allergens within the observation period of the study [Срок оценки: 2 years]
The association of food allergy related quality of life, measured via the Food Allergy Quality of Life Questionnaire, with repetitive allergic reactions [Срок оценки: 2 years]
The association of eating habits (e.g. frequency of eating out) and the occurrence of repetitive allergic reactions [Срок оценки: 2 years]
Use of emergency medication during a repetitive reaction [Срок оценки: 2 years]
Use of adrenaline as first line treatment [Срок оценки: 2 years]
The association of dietary counselling and successful allergen avoidance [Срок оценки: 2 years]

Критерии участия

Критерии включения

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