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

2026年7月22日 更新者: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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of sensitization to clinically relevant fish allergen components.
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Sensitization to individual fish allergen components
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年7月18日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月27日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • FASC-2026-001
  • R-0012/26 (其他标识符:Clinical Research Ethics Committee (CEIm), Hospital Infantil Universitario Niño Jesús, Madrid, Spain)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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