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

2026년 7월 22일 업데이트: 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.

연구 개요

상태

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정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

120

참여기준

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자격 기준

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어린이

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아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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주요 결과 측정

결과 측정	측정값 설명	기간
Prevalence of sensitization to clinically relevant fish allergen components. 기간: 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)

2차 결과 측정

결과 측정	측정값 설명	기간
Sensitization to individual fish allergen components 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Carmelo Escudero

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2026년 7월 18일

QC 기준을 충족하는 최초 제출

2026년 7월 22일

처음 게시됨 (실제)

2026년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)