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Enrolling by Invitation

NCT Number: NCT06947252

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Food Allergies Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral food challenge test

Diagnostic Test

Oral food challenge test at home or in the hospital

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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