IgE-Mediated Fish Allergy in Spanish Children and Adolescents: A Multicenter Prospective Study of New-Onset Cases and Sensitization Profiles.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Prevalence of sensitization to clinically relevant fish allergen components.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of sensitization to clinically relevant fish allergen components.
时间窗: 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.
次要结局
- Sensitization to individual fish allergen components(Baseline (Day 1))
- Specific IgE sensitization profile(Baseline (Day 1))
- Oral food challenge outcome(During the diagnostic evaluation (up to 3 months after baseline (Day 1)))
- Health-related quality of life(Baseline (Day 1) and at completion of the diagnostic evaluation (up to 3 months after baseline (Day 1)))
- Geographical variability in sensitization profiles(Through study completion, an average of 18 months)
研究者
Carmelo Escudero
Head of the Pediatric Allergy Section, Hospital Infantil Universitario Niño Jesús
Hospital Infantil Universitario Niño Jesús, Madrid, Spain