NCT04552522

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

September 13, 2020

Last Update Submit

April 21, 2025

Conditions

Keywords

Shrimp allergyOral immunotherapySpecific Immunoglobulin ESkin sensitization

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

EXPERIMENTAL

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

Other: shrimp allergy with intend to eat shrimp

Shrimp allergy with avoid shrimp

NO INTERVENTION

Case shrimp allergy with avoid shrimp

Interventions

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

Shrimp allergy with Intend to eat shrimp

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

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

  • Punchama Pacharn, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

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

Locations