Atopic DermatitisNCT06947252
Frequency of Food Allergy Confirm by Oral Food Challenge Among Foods Avoidance in Atopic Dermatitis Children
A study testing Oral food challenge test in people with Atopic Dermatitis and Food Allergies, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Atopic Dermatitis, Food Allergies
- What is being tested?
- Oral food challenge test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 29 Jan 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Being tested
- Oral food challenge test
- Keywords
- Atopic dermatitis, Food allergies, Oral food challenge test
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challenge testDiagnostic test
Oral food challenge test at home or in the hospital
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis children that avoid some foods | Experimental | Oral food challenge test Receives: Diagnostic Test: Oral food challenge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
Type of food reaction after oral food challenge test in atopic dermatitis children
Type of food reaction after oral food challenge test in atopic dermatitis children divide to IgE mediated or delayed type (AD flare)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start29 Jan 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punchama Pacharn, Principal investigator, Mahidol University, Siriraj Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947252
- Sponsor's protocol ID
- 998/2567(IRB3)
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30326323
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Food Allergies in Pediatric Atopic Dermatitis Patients Practicing Food Avoidance
- ClinicalTrials.gov ID
- NCT06947252
- Acronym / sponsor ID
- 998/2567(IRB3)
- Conditions
- Atopic Dermatitis, Food Allergies
- Keywords
- Atopic dermatitis, Food allergies, Oral food challenge test
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis children that avoid some foods | Experimental | Diagnostic Test: Oral food challenge testOral food challenge test |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral food challenge testOral food challenge test at home or in the hospital | Diagnostic test | Atopic dermatitis children that avoid some foods |
Primary outcome
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
1 secondary outcome
Type of food reaction after oral food challenge test in atopic dermatitis children
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 30326323Eapen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Punchama Pacharn principal investigator
Mahidol University, Siriraj Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral food challenge test in people with Atopic Dermatitis and Food Allergies, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of food allergy among foods avoidance in atopic dermatitis children (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.