Immunological Response After Shrimp Oral Immunotherapy Treatment

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04552522

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy to Shrimp Immunotherapy	Other: shrimp allergy with intend to eat shrimp	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Immunological Response After Shrimp Oral Immunotherapy Treatment

Actual Study Start Date :

Aug 28, 2020

Anticipated Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shrimp allergy with Intend to eat shrimp 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 intend to eat shrimp and treat with oral immunotherapy
No Intervention: Shrimp allergy with avoid shrimp Case shrimp allergy with avoid shrimp

Arm

Intervention/Treatment

Experimental: Shrimp allergy with Intend to eat shrimp

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 intend to eat shrimp and treat with oral immunotherapy

No Intervention: Shrimp allergy with avoid shrimp

Case shrimp allergy with avoid shrimp

Outcome Measures

Primary Outcome Measures

specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen [1 year]
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 [1 year]
To follow up adverse event from Shrimp oral immunotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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