Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time

NCT03645629 | Completed

• 1 other identifier: 619/2556 (EC 3)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison the result of skin prick tests and atopy patch test of lyophilized food extracts at different storage time (0, 3 and 6 months) after preparation

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• skin test result of lyophilized foods at 6 months after preparation

  Perform skin prick test and atopy patch test the patients with lyophilized foods at 0, 3 and 6 months after preparation and compare the results at 6 months to 0 and 3 months.

  6 month

Study Arms (3)

Food skin tests at 0 month

ACTIVE COMPARATOR

the skin test results of food extract at time 0 months after preparation

Diagnostic Test: skin test with food at different storage times

Food skin tests at 3 month

ACTIVE COMPARATOR

the skin test results of food extract at time 3 months after preparation

Diagnostic Test: skin test with food at different storage times

Food skin tests at 6 month

ACTIVE COMPARATOR

the skin test results of food extract at time 6 months after preparation

Diagnostic Test: skin test with food at different storage times

Interventions

skin test with food at different storage times DIAGNOSTIC_TEST

Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Food skin tests at 0 month; Food skin tests at 3 month; Food skin tests at 6 month

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• mild to moderately severe food allergy patients
• At least positive skin test to one kind of common food (commercial extract)
• Stop antihistamine or corticosteroid (if more than 20mg/day) for at least 7 days

You may not qualify if:

• Dermographism
• Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
• Severe dermatitis or large area involment
• pregnancy

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital. Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Nualanong Visitsunthorn, MD

  Department of Pediatrics, Siriraj hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Perform skin prick test and atopy patch test of lyophilized foods (cow milk, egg white, egg yolk, wheat, soy and shrimp) stored at different time; 0, 3 and 6 months after preparation. Then compare the results.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 24, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

TH (1)