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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
Prevalence of sensitization to clinically relevant fish allergen components.
Distribution of molecular sensitization profiles to clinically relevant fish allergen components and allergenic protein families in children and adolescents with newly diagnosed IgE-mediated fish allergy, as determined by component-resolved diagnostics performed at study enrollment.
Time frame: Baseline (Day 1)
Sensitization to individual fish allergen components
Frequency and distribution of sensitization to individual fish allergen components and allergenic protein families measured by component-resolved diagnostics.
Time frame: Baseline (Day 1)
Specific IgE sensitization profile
Serum specific IgE sensitization to fish species and allergenic components determined using standardized laboratory methods.
Time frame: Baseline (Day 1)
Oral food challenge outcome
Results of oral food challenges, including confirmation of clinical allergy and identification of tolerated fish species, when clinically indicated.
Time frame: During the diagnostic evaluation (up to 3 months after baseline (Day 1))
Health-related quality of life
Health-related quality of life assessed using validated food allergy-specific quality-of-life questionnaires.
Time frame: Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
Geographical variability in sensitization profiles
Comparison of molecular sensitization profiles and clinical characteristics across participating regions in Spain.
Time frame: Through study completion, an average of 18 months
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