NCT07501325

Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy

Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Food Hypersensitivity
• Shellfish Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral Food Challenge (OFC)	Oral food challenge with shrimp performed according to the study protocol to confirm or exclude IgE-mediated shrimp allergy in children with suspected shrimp allergy. To standardize the challenge material, black tiger shrimp (Penaeus monodon) will be used in all participants. Additional oral food challenges using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. The oral food challenge result serves as the reference standard for diagnostic evaluation in this study.
DIAGNOSTIC_TEST	Skin Prick Test	Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.
DIAGNOSTIC_TEST	Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement	Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2026-03-30
• Last updated: 2026-04-06

Locations

1 site across 1 country: Vietnam