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

NCT06947252 | Enrolling By Invitation

• 1 other identifier: 998/2567(IRB3)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis; Food Allergies

Keywords

Atopic dermatitis; Food allergies; Oral food challenge test

Outcome Measures

Primary Outcomes (1)

• Frequency of food allergy among foods avoidance in atopic dermatitis children

  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 Outcomes (1)

• Type of food reaction after oral food challenge test in atopic dermatitis children

  7 days

Study Arms (1)

Atopic dermatitis children that avoid some foods

EXPERIMENTAL

Oral food challenge test

Diagnostic Test: Oral food challenge test

Interventions

Oral food challenge test DIAGNOSTIC_TEST

Oral food challenge test at home or in the hospital

Atopic dermatitis children that avoid some foods

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

• Eapen AA, Kloepfer KM, Leickly FE, Slaven JE, Vitalpur G. Oral food challenge failures among foods restricted because of atopic dermatitis. Ann Allergy Asthma Immunol. 2019 Feb;122(2):193-197. doi: 10.1016/j.anai.2018.10.012. Epub 2018 Oct 14.

  PMID: 30326323 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Punchama Pacharn

  Mahidol University, Siriraj Hospital, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)