FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents (FASC)
IgE-Mediated Fish Allergy in Spanish Children and Adolescents: A Multicenter Prospective Study of New-Onset Cases and Sensitization Profiles.
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of sensitization to clinically relevant fish allergen components.
Prazo: Baseline (Day 1)
|
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.
|
Baseline (Day 1)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitization to individual fish allergen components
Prazo: Baseline (Day 1)
|
Frequency and distribution of sensitization to individual fish allergen components and allergenic protein families measured by component-resolved diagnostics.
|
Baseline (Day 1)
|
|
Specific IgE sensitization profile
Prazo: Baseline (Day 1)
|
Serum specific IgE sensitization to fish species and allergenic components determined using standardized laboratory methods.
|
Baseline (Day 1)
|
|
Oral food challenge outcome
Prazo: During the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
Results of oral food challenges, including confirmation of clinical allergy and identification of tolerated fish species, when clinically indicated.
|
During the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
|
Health-related quality of life
Prazo: Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
Health-related quality of life assessed using validated food allergy-specific quality-of-life questionnaires.
|
Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1))
|
|
Geographical variability in sensitization profiles
Prazo: Through study completion, an average of 18 months
|
Comparison of molecular sensitization profiles and clinical characteristics across participating regions in Spain.
|
Through study completion, an average of 18 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FASC-2026-001
- R-0012/26 (Outro identificador: Clinical Research Ethics Committee (CEIm), Hospital Infantil Universitario Niño Jesús, Madrid, Spain)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .