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Immunological Response After Shrimp Oral Immunotherapy Treatment

Primary Purpose

Allergy to Shrimp, Immunotherapy

Status
Active
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
shrimp allergy with intend to eat shrimp
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy to Shrimp focused on measuring Shrimp allergy, Oral immunotherapy, Specific Immunoglobulin E, Skin sensitization

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shrimp allergy with Intend to eat shrimp

Shrimp allergy with avoid shrimp

Arm Description

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

Case shrimp allergy with avoid shrimp

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse event from Shrimp oral immunotherapy
To follow up adverse event from Shrimp oral immunotherapy

Full Information

First Posted
September 13, 2020
Last Updated
October 20, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04552522
Brief Title
Immunological Response After Shrimp Oral Immunotherapy Treatment
Official Title
Immunological Response After Shrimp Oral Immunotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy to Shrimp, Immunotherapy
Keywords
Shrimp allergy, Oral immunotherapy, Specific Immunoglobulin E, Skin sensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shrimp allergy with Intend to eat shrimp
Arm Type
Experimental
Arm Description
Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp
Arm Title
Shrimp allergy with avoid shrimp
Arm Type
No Intervention
Arm Description
Case shrimp allergy with avoid shrimp
Intervention Type
Other
Intervention Name(s)
shrimp allergy with intend to eat shrimp
Intervention Description
shrimp allergy with intend to eat shrimp and treat with oral immunotherapy
Primary Outcome Measure Information:
Title
specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen
Description
To follow-up the level of specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse event from Shrimp oral immunotherapy
Description
To follow up adverse event from Shrimp oral immunotherapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29205393
Citation
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.
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Immunological Response After Shrimp Oral Immunotherapy Treatment

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