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

August 12, 2019 updated by: Nualanong Visitsunthorn, Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital. Mahidol University

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 (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

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

Sponsor

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, 2018

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (ACTUAL)

August 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 619/2556 (EC 3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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