Frequency of Food Allergy Confirm by Oral Food Challenge Among Foods Avoidance in Atopic Dermatitis Children

April 21, 2025 updated by: Mahidol University

Validation of Food Allergies in Pediatric Atopic Dermatitis Patients Practicing Food Avoidance

Atopic dermatitis can be caused by several factors, including food allergy. Currently, the diagnosis of food allergy often performing skin tests and measuring specific IgE foods that many studies have shown that about 53% of children with atopic dermatitis have food sensitization, result in avoidance of food intake. But only 15% are confirmed to have a true food allergy, so the purpose of our study is to find the prevalence of food allergy in Thai children with atopic dermatitis who are avoiding some foods, using the oral food challenge to confirm the diagnosis to reduce unnecessary food avoidance and prevent complications from inappropriate dietary restrictions

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

All subject in this study were patients with history of atopic dermatitis and avoid at least 1 food of egg yolk, egg white, cow milk, peanut, wheat or soy. All of them will undergo a blood testing for specific IgE foods to assess whether they can resume consuming that particular food or they must perform oral food challenge test in hospital to evaluate whether they truly have a food allergy or should continue to avoid that food.

The primary outcome was to study frequency of food allergy confirm by oral food challenge among foods avoidance in atopic dermatitis children, focusing on the 6 major food allergens in the Thai children: egg yolk, egg white, cow milk, peanut, wheat and soy. Other outcomes were study type of food reaction after oral food challenge test in atopic dermatitis children (IgE mediated, delayed type: AD flare)

Study Type

Interventional

Enrollment (Estimated)

200

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

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≤ 6 years
  • Age ≤ 6 years with diagnosis of atopic dermatitis c
  • Now parent report them avoid at least 1 food of egg yolk, egg white, cow milk, peanut, wheat or soy

Exclusion Criteria:

  • Specific IgE food > 95%PPV (73-74%PPV in wheat, soy)
  • Patients with uncontrolled asthma/ atopic dermatitis
  • Patients who had been treated with some other immunotherapy e.g. SCIT, OIT
  • Patients with delayed developmental problem or mental disorder
  • Patient use beta-blocker, ACEI, ARB
  • Patient who unable to follow up

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atopic dermatitis children that avoid some foods
Oral food challenge test
Diagnostic test: Oral food challenge test
Oral food challenge test at home or in the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of food allergy among foods avoidance in atopic dermatitis children
Time Frame: 7 days
Frequency of food allergy confirm by oral food challenge among foods avoidance in atopic dermatitis children, focusing on the 6 major food allergens in the Thai children: egg yolk, egg white, cow milk, peanut, wheat, soy
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of food reaction after oral food challenge test in atopic dermatitis children
Time Frame: 7 days
Type of food reaction after oral food challenge test in atopic dermatitis children divide to IgE mediated or delayed type (AD flare)
7 days

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Punchama Pacharn, Mahidol University, Siriraj Hospital, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 29, 2025

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 998/2567(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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