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

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ClinicalTrials.gov Identifier: NCT03645629
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

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

Condition or disease Intervention/treatment Phase
Food Allergy Diagnostic Test: skin test with food at different storage times Not Applicable

Detailed Description:

Skin prick test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation.

Atopy patch test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Skin Prick Tests and Atopy Patch Test Results of Lyophilized Food Extracts at Different Storage Time (0, 3 and 6 Months) After Preparation
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: Food skin tests at 0 month
the skin test results of food extract at time 0 months after preparation
Diagnostic Test: skin test with food at different storage times
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Active Comparator: Food skin tests at 3 month
the skin test results of food extract at time 3 months after preparation
Diagnostic Test: skin test with food at different storage times
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Active Comparator: Food skin tests at 6 month
the skin test results of food extract at time 6 months after preparation
Diagnostic Test: skin test with food at different storage times
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results




Primary Outcome Measures :
  1. skin test result of lyophilized foods at 6 months after preparation [ Time Frame: 6 month ]
    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.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645629


Contacts
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Contact: Nualanong Visitsunthorn, MD 2197000 ext 55941 nualsri@gmail.com
Contact: Chweewan Sripramong 2197000 ext 95889 c_thomachote@hotmail.com

Locations
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Thailand
Siriraj Hospital. Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Nualanong Visitsunthorn, MD    024197000 ext 95941    nualanongv@yahoo.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Nualanong Visitsunthorn, MD Department of Pediatrics, Siriraj hospital, Mahidol University

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Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03645629     History of Changes
Other Study ID Numbers: 619/2556 (EC 3)
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases