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

NCT07501325 | Not Yet Recruiting

• 1 other identifier: UMP-SHRIMP-IgE-2025
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Shrimp Allergy; Food Hypersensitivity; IgE-Mediated Allergy

Keywords

Oral Food Challenge; Skin Prick Test; Tropomyosin; Hemocyanin; Specific IgE; Recombinant Allergen; shrimp allergy; Shellfish Allergy; Children

Outcome Measures

Primary Outcomes (1)

• Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy

  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.

  At the time of the oral food challenge during the baseline diagnostic evaluation

Secondary Outcomes (3)

• 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

Study Arms (1)

Children With Suspected IgE-Mediated Shrimp Allergy

EXPERIMENTAL

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.

Diagnostic Test: Oral Food Challenge (OFC); Diagnostic Test: Skin Prick Test; Diagnostic Test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement

Interventions

Oral Food Challenge (OFC) DIAGNOSTIC_TEST

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.

Children With Suspected IgE-Mediated Shrimp Allergy

Skin Prick Test DIAGNOSTIC_TEST

Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.

Children With Suspected IgE-Mediated Shrimp Allergy

Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement DIAGNOSTIC_TEST

Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.

Children With Suspected IgE-Mediated Shrimp Allergy

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 16 years.
• Evaluated at the Allergy Unit of Children's Hospital 1.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• Children's Hospital Number 1, Ho Chi Minh City, Vietnam: collaborator

Study Sites (1)

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

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Food Hypersensitivity; Shellfish Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Tu HK Trinh, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngoc Thi Nguyen, MD

CONTACT

+84 908 876 976; ntngoc.ncs25@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Student

Model Details: All enrolled children with suspected IgE-mediated shrimp allergy will undergo the same study procedures, including oral food challenge, skin prick testing, blood sampling, and measurement of recombinant tropomyosin- and hemocyanin-specific IgE.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)