FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents

Официальное название

IgE-Mediated Fish Allergy in Spanish Children and Adolescents: A Multicenter Prospective Study of New-Onset Cases and Sensitization Profiles.

Обзор

Fish allergy is one of the leading causes of food-induced allergic reactions in children, but the clinical presentation and patterns of sensitization vary considerably among patients and geographical regions. This prospective multicenter observational study aims to characterize children and adolescents with newly diagnosed IgE-mediated fish allergy in Spain. Clinical information, diagnostic test results, and molecular sensitization profiles will be collected using standardized procedures across participating centers. Molecular allergy assessment will include component-resolved diagnostics to evaluate sensitization to major fish allergens and other relevant allergenic protein families. The study will also assess disease severity, quality of life, and regional differences in sensitization patterns. The results are expected to improve the understanding of pediatric fish allergy in Spain and contribute to more accurate diagnosis, risk assessment, and personalized management of affected patients.

Подробное описание

Fish allergy is a major cause of IgE-mediated food allergy in children and is associated with a wide spectrum of clinical manifestations, ranging from mild reactions to severe anaphylaxis. Current knowledge of pediatric fish allergy is limited by geographical differences in dietary habits, fish species consumed, and patterns of allergen sensitization. Although component-resolved diagnostics have improved the characterization of fish allergy, comprehensive multicenter studies in children remain scarce.

The FASC study is a prospective, multicenter, observational study conducted in Spain to characterize children and adolescents with newly diagnosed IgE-mediated fish allergy. Consecutive eligible patients will be recruited in participating pediatric allergy units using standardized diagnostic and data collection procedures. Clinical information, allergy history, skin testing, serum specific IgE measurements, and molecular sensitization profiles will be collected. When clinically indicated, oral food challenges will be performed according to international recommendations and routine clinical practice.

The study aims to describe clinical phenotypes, molecular sensitization patterns, disease severity, quality of life, and geographical variability across Spain. The findings are expected to improve the understanding of pediatric fish allergy, support the identification of clinically relevant sensitization profiles, and contribute to more accurate diagnosis and individualized patient management.

Первичные конечные точки

• Prevalence of sensitization to clinically relevant fish allergen components. [Срок оценки: Baseline (Day 1)]

Вторичные конечные точки (5)

• Sensitization to individual fish allergen components [Срок оценки: Baseline (Day 1)]
• Specific IgE sensitization profile [Срок оценки: Baseline (Day 1)]
• Oral food challenge outcome [Срок оценки: During the diagnostic evaluation (up to 3 months after baseline (Day 1))]
• Health-related quality of life [Срок оценки: Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))]
• Geographical variability in sensitization profiles [Срок оценки: Through study completion, an average of 18 months]

Критерии участия

Критерии включения

• Children and adolescents aged 0 to 17 years (up to 18 years of age).
• First clinical episode compatible with IgE-mediated fish allergy.
• Evidence of allergic sensitization demonstrated by at least one of the following:
• Positive skin prick test (wheal diameter ≥3 mm compared with the negative control); or
• Serum specific IgE ≥0.35 kUA/L to at least one fish species or fish allergen component.
• Written informed consent obtained from the parent(s) or legal guardian(s), and assent from participants aged 12 years or older, when applicable.

Критерии исключения

• Age ≥18 years.
• Non-IgE-mediated fish allergy (e.g., fish-induced FPIES).
• Severe dermographism, chronic urticaria, or severe atopic dermatitis preventing reliable interpretation of skin prick testing.
• Inability to complete the diagnostic procedures required by the study.
• Absence of informed consent or, when applicable, participant assent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07727148 · FASC-2026-001 · R-0012/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗