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

NCT ID: NCT06947252

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2029-06-30

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

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)

Conditions

Atopic Dermatitis; Food Allergies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Atopic dermatitis children that avoid some foods

Oral food challenge test

Group Type: EXPERIMENTAL

Oral food challenge test

Intervention Type: DIAGNOSTIC_TEST

Oral food challenge test at home or in the hospital

Interventions

Oral food challenge test

Oral food challenge test at home or in the hospital

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Punchama Pacharn

Role: PRINCIPAL_INVESTIGATOR

Mahidol University, Siriraj Hospital, Thailand

Locations

Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 30326323 (View on PubMed)

Other Identifiers

998/2567(IRB3)

Identifier Type: -

Identifier Source: org_study_id