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

22 juli 2026 bijgewerkt door: Carmelo Escudero

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

120

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population consists of children and adolescents evaluated for suspected fish allergy in the Allergy Units of participating hospitals across Spain. Participants will be recruited consecutively from routine clinical practice at tertiary referral centers that are members of the Spanish Society of Allergy and Clinical Immunology (SEAIC). The study includes patients from multiple geographical regions, providing a representative sample of the Spanish pediatric population referred for specialized allergy assessment.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Prevalence of sensitization to clinically relevant fish allergen components. Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Sensitization to individual fish allergen components Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Carmelo Escudero

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

18 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2026

Eerst geplaatst (Werkelijk)

27 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)