Skip to main content
Clinical Trials/NCT04552522
NCT04552522CompletedNot Applicable

Immunological Response After Shrimp Oral Immunotherapy Treatment

Mahidol University1 site in 1 country20 target enrollmentStarted: August 28, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in Eliciting Dose of Shrimp During Oral Food Challenge

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: shrimp allergy with intend to eat shrimp (Other)

Shrimp allergy with avoid shrimp

No Intervention

Case shrimp allergy with avoid shrimp

Outcomes

Primary Outcomes

Change in Eliciting Dose of Shrimp During Oral Food Challenge

Time Frame: Baseline and 12 months

Change in the eliciting dose (ED) of shrimp protein during oral food challenge from baseline to 12 months in participants with shrimp allergy undergoing shrimp oral immunotherapy compared with avoidance.

specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen

Time Frame: 1 year

To follow-up the level of specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen

Secondary Outcomes

  • Adverse Event From Shrimp Oral Immunotherapy(1 year)
  • Adverse event from Shrimp oral immunotherapy(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials