Food HypersensitivityNCT07501325
Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
A study testing Oral Food Challenge (OFC), Skin Prick Test and Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement in people with Food Hypersensitivity and Shellfish Allergy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Food Hypersensitivity, Shellfish Allergy
- What is being tested?
- Oral Food Challenge (OFC), Skin Prick Test and Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Children's Hospital 1
Ho Chi Minh City
Ngoc Thi Nguyen, MD, +84 908 876 976, ntngoc.ncs25@ump.edu.vn
Ngoc Thi Nguyen, MD
About this study
Official title: Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam
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.
Read the 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
- Being tested
- Oral Food Challenge (OFC), Skin Prick Test, Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement
- Keywords
- Oral Food Challenge, Skin Prick Test, Tropomyosin, Hemocyanin, Specific IgE, Recombinant Allergen, Shellfish Allergy, Children, Food Hypersensitivity, Shrimp Allergy
- Medical subject headings
- Food Hypersensitivity, Shellfish Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Skin Prick TestDiagnostic test
Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.
Recombinant Tropomyosin- and Hemocyanin-Specific IgE MeasurementDiagnostic test
Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Oral Food Challenge (OFC); Diagnostic Test: Skin Prick Test; Diagnostic Test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Diagnostic performance of recombinant tropomyosin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: During the baseline diagnostic evaluation
Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Diagnostic performance of recombinant hemocyanin-specific IgE will be evaluated against oral food challenge results, including receiver operating characteristic analysis, area under the curve, optimal cutoff, sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: 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
A combined diagnostic model using recombinant tropomyosin-specific IgE, recombinant hemocyanin-specific IgE, clinical history suggestive of shrimp allergy, and skin prick test results will be evaluated against oral food challenge results. Model performance will include receiver operating characteristic analysis and area under the curve.
Measured: During the baseline diagnostic evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start10 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Number 1, Ho Chi Minh City, Vietnam
- Responsible party
- Principal investigator, Ngoc Thi Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Tu HK Trinh, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501325
- Sponsor's protocol ID
- UMP-SHRIMP-IgE-2025
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam
- ClinicalTrials.gov ID
- NCT07501325
- Acronym / sponsor ID
- UMP-SHRIMP-IgE-2025
- Conditions
- Food Hypersensitivity, Shellfish Allergy
- Keywords
- Oral Food Challenge, Skin Prick Test, Tropomyosin, Hemocyanin, Specific IgE, Recombinant Allergen, Shellfish Allergy, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Children's Hospital Number 1, Ho Chi Minh City, Vietnam
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Children With Suspected IgE-Mediated Shrimp Allergy | Experimental | Diagnostic Test: Oral Food Challenge (OFC), Diagnostic Test: Skin Prick Test, Diagnostic Test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE MeasurementChildren 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. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Children With Suspected IgE-Mediated Shrimp Allergy |
| Skin Prick TestSkin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy. | Diagnostic test | Children With Suspected IgE-Mediated Shrimp Allergy |
| Recombinant Tropomyosin- and Hemocyanin-Specific IgE MeasurementBlood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy. | Diagnostic test | Children With Suspected IgE-Mediated Shrimp Allergy |
Primary outcome
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy
Time frame: 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.
3 secondary outcomes
Diagnostic Accuracy of Recombinant Tropomyosin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Time frame: During the baseline diagnostic evaluation
Diagnostic Accuracy of Recombinant Hemocyanin-Specific IgE for Oral Food Challenge-Confirmed Shrimp Allergy
Time frame: 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
Time frame: During the baseline diagnostic evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tu HK Trinh, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Food Challenge (OFC), Skin Prick Test and Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement in people with Food Hypersensitivity and Shellfish Allergy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ngoc Thi Nguyen, MD (+84 908 876 976, ntngoc.ncs25@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Food Challenge-Confirmed IgE-Mediated Shrimp Allergy (time frame: At the time of the oral food challenge during the baseline diagnostic evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.