Immunological Response After Shrimp Oral Immunotherapy Treatment
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2020
CompletedFirst Submitted
Initial submission to the registry
September 13, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedApril 22, 2025
April 1, 2025
4.2 years
September 13, 2020
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse event from Shrimp oral immunotherapy
1 year
Study Arms (2)
Shrimp allergy with Intend to eat shrimp
EXPERIMENTALCase shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp
Shrimp allergy with avoid shrimp
NO INTERVENTIONCase shrimp allergy with avoid shrimp
Interventions
shrimp allergy with intend to eat shrimp and treat with oral immunotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Related 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.
PMID: 29205393BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Punchama Pacharn, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2020
First Posted
September 17, 2020
Study Start
August 28, 2020
Primary Completion
October 31, 2024
Study Completion
December 30, 2024
Last Updated
April 22, 2025
Record last verified: 2025-04