Immunological Response After Shrimp Oral Immunotherapy Treatment

NCT ID: NCT04552522

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergy to Shrimp Immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shrimp allergy with Intend to eat shrimp

Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp

Group Type EXPERIMENTAL

shrimp allergy with intend to eat shrimp

Intervention Type OTHER

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

Shrimp allergy with avoid shrimp

Case shrimp allergy with avoid shrimp

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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shrimp allergy with intend to eat shrimp

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Punchama Pacharn, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 29205393 (View on PubMed)

Other Identifiers

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090/2563

Identifier Type: -

Identifier Source: org_study_id

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