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

NCT07501325 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Food Hypersensitivity
  • Shellfish Allergy

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital Number 1, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Principal Investigators

  • Tu HK Trinh, MD, PhD · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-03-31
Completion
2028-04-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501325 on ClinicalTrials.gov