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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 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

120

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Prevalence of sensitization to clinically relevant fish allergen components. Tidsram: 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)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Sensitization to individual fish allergen components Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Carmelo Escudero

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 december 2027

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

18 juli 2026

Först inskickad som uppfyllde QC-kriterierna

22 juli 2026

Första postat (Faktisk)

27 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)