Efficacy of Local Food Extracts at Different Storage Times

March 13, 2019 updated by: Nualanong Visitsunthorn, Mahidol University

Efficacy of Local Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Times (0, 3 and 6 Months)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nualanong Visitsunthorn, Professor
  • Phone Number: 95941 024197000
  • Email: nualanongv@yahoo.com

Study Contact Backup

  • Name: Orathai Jirapongsananurak, Prof
  • Phone Number: 95942 024197000
  • Email: jirapongo@yahoo.com

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Food allergy cases aged 3-18 years old.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Nualanong Visitsunthorn, Prof, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

August 31, 2019

Study Completion (Anticipated)

August 31, 2019

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 619/2556(EC3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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