Immunological Response After Shrimp Oral Immunotherapy Treatment

Immunotherapy Clinical Trial

Official title:

Immunological Response After Shrimp Oral Immunotherapy Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04552522
• Other study ID #: 090/2563
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Allergy to Shrimp
• Hypersensitivity
• Immunotherapy

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