Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy
研究概览
简要总结
This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.
详细描述
Shrimp allergy is an important cause of IgE-mediated food allergy in children, and diagnosis remains challenging because conventional tests may not reliably distinguish true clinical allergy from sensitization or cross-reactivity. Oral food challenge (OFC) remains the reference standard, but it is time-consuming, resource-intensive, and may trigger significant allergic reactions.
This interventional diagnostic study will enroll children with suspected IgE-mediated shrimp allergy. Participants will undergo OFC according to the study protocol, together with skin prick testing and blood sampling for measurement of specific IgE to recombinant tropomyosin and hemocyanin. To standardize the diagnostic procedure, OFC will be performed using black tiger shrimp (Penaeus monodon) in all participants. Additional OFCs using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. OFC results will be used to classify participants as shrimp allergic or shrimp tolerant.
The study will estimate the proportion of true shrimp allergy among children with suspected shrimp allergy and evaluate the diagnostic performance of recombinant tropomyosin- and hemocyanin-specific IgE, alone and in combination with clinical history and skin prick test results. The findings are expected to support more accurate molecular diagnosis of shrimp allergy in children and help optimize the indication for OFC in clinical practice in Vietnam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking is used for study assignment. However, laboratory personnel performing recombinant tropomyosin- and hemocyanin-specific IgE measurements are independent of the clinical team and are blinded to participants' oral food challenge results at the time of laboratory assessment.
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 16 years.
- •Evaluated at the Allergy Unit of Children's Hospital
- •Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures.
- •Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate.
排除标准
- •Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation.
- •Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.
- •Mental or behavioral disorder that prevents completion of study procedures.
- •Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.
- •Exclusion Criteria:
- •Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation; participants may be rescheduled after recovery.
- •Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.
- •Mental or behavioral disorder that prevents completion of study procedures.
- •Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.
研究组 & 干预措施
Children With Suspected IgE-Mediated Shrimp Allergy
Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.
干预措施: Oral Food Challenge (OFC) (Diagnostic Test)
Children With Suspected IgE-Mediated Shrimp Allergy
Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.
干预措施: Skin Prick Test (Diagnostic Test)
Children With Suspected IgE-Mediated Shrimp Allergy
Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.
干预措施: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement (Diagnostic Test)
结局指标
主要结局
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy
时间窗: At the time of the oral food challenge during the baseline diagnostic evaluation
Participants will be classified as having true IgE-mediated shrimp allergy if the oral food challenge is positive according to the study protocol. A negative oral food challenge indicates shrimp tolerance. Oral food challenge results will be used as the reference standard for subsequent diagnostic performance analyses.
次要结局
- Diagnostic Accuracy of Recombinant Tropomyosin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy(During the baseline diagnostic evaluation)
- Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy(During the baseline diagnostic evaluation)
- Diagnostic Accuracy of a Combined Model Incorporating Recombinant Tropomyosin-Specific IgE, Recombinant Hemocyanin-Specific IgE, Clinical History, and Skin Prick Test(During the baseline diagnostic evaluation)
研究者
Ngoc Thi Nguyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City