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Efficacy of Local Food Extracts at Different Storage Times

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ClinicalTrials.gov Identifier: NCT02774629
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

Brief Summary:
Local lyophylized food extracts are available useful in skin prick test and atopy patch test to confirm food allergy. However, the investigators want to know the duration that the investigators can keep the extracts for the usage in this purpose.

Condition or disease Intervention/treatment
Food Allergy Other: prick and patch test

Detailed Description:
Food allergy incidence increases world wide. The diagnosis mostly depends on history. Skin prick test and atopic patch test are useful in finding the causative foods in some cases. The local food extracts have been shown to be at least as effective as commercial ones. From previous study the investigators keep the extract at 2-8 degree Celsius for 1-3 months for the usage. The investigators want to evaluate the duration that the extracts are still useful in diagnosis food allergy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Local Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Times (0, 3 and 6 Months)
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: prick and patch test
    The cases are pricked and patched with local food allergen extract at different storage times (0, 3 and 6 months after preparation)


Primary Outcome Measures :
  1. Mean wheal diameter of skin prick test [ Time Frame: 2 years ]
    The skin prick tests are performed with local prepared food allergen at keeping time of 0, 3 and 6 months after the preparation.


Secondary Outcome Measures :
  1. Result of atopy patch test [ Time Frame: 2 years ]
    atopy patch tests are performed with local prepared food allergen at keeping time of 0, 3 and 6 months after the preparation.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Food allergy cases aged 3-18 years old.
Criteria

Inclusion Criteria:

  • Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)

Exclusion Criteria:

  • Chronic diseases such as heart disease, liver, renal and severe sepsis
  • Severe allergic symptoms such as anaphylaxis
  • Extensive skin rashes
  • 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): NCT02774629


Contacts
Contact: Nualanong Visitsunthorn, Professor 024197000 ext 95941 nualanongv@yahoo.com
Contact: Orathai Jirapongsananurak, Prof 024197000 ext 95942 jirapongo@yahoo.com

Locations
Thailand
Siriraj hospital Recruiting
Bangkok, Thailand, 10700
Contact: Nualanong Visitsunthorn, Prof    024197000 ext 95941    nualanongv@yahoo.com   
Contact: Orathai Jirapongsananurak, Prof    024197000 ext 95942    jirapongo@yahoo.com   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Nualanong Visitsunthorn, Prof Mahidol University

Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02774629     History of Changes
Other Study ID Numbers: 619/2556(EC3)
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nualanong Visitsunthorn, Mahidol University:
food allergy
skin prick test
atopy patch test

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