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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04552522
Other study ID # 090/2563
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 28, 2020
Est. completion date April 30, 2024

Study information

Verified date October 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.


Description:

All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 40 Years
Eligibility Inclusion Criteria: - Age 12 - 40 years old - History of Immunoglobulin E-mediated shrimp allergy > 3 episode/year or disturb quality of life - Positive oral food challenge test for shrimp Exclusion Criteria: - History of shrimp anaphylaxis (include cardiovascular or neurological symptoms) - Shellfish dependent exercise induced anaphylaxis - History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis - History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker

Study Design


Related Conditions & MeSH terms


Intervention

Other:
shrimp allergy with intend to eat shrimp
shrimp allergy with intend to eat shrimp and treat with oral immunotherapy

Locations

Country Name City State
Thailand Siriraj Hospital Bangkoknoi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen To follow-up the level of specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen 1 year
Secondary Adverse event from Shrimp oral immunotherapy To follow up adverse event from Shrimp oral immunotherapy 1 year
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