Investigating the impact of ultra-processed foods on children's atopic dermatitis
The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project
This study is trying to see if eating ultra-processed foods makes atopic dermatitis worse in children aged 6 months to 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Months to 10 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06996327 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the potential role of dietary consumption of ultra-processed foods (UPFs) in the development and exacerbation of atopic dermatitis (AD) in children aged 6 months to 10 years. It will involve evaluating the dietary habits of both children diagnosed with AD and healthy controls matched for age and sex. The study seeks to understand how UPFs may influence the pathogenesis of AD, which is characterized by chronic inflammation and skin barrier dysfunction. Participants will be recruited from the University of Naples Federico II, where informed consent will be obtained from parents or guardians.
Who should consider this trial
Good fit: Ideal candidates for this study are Caucasian children aged 6 months to 10 years with a confirmed diagnosis of atopic dermatitis.
Not a fit: Patients who are non-Caucasian, outside the age range, or have other chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary modifications that may help manage or prevent atopic dermatitis in children.
How similar studies have performed: While the role of diet in atopic dermatitis is being explored, this specific focus on ultra-processed foods is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caucasian subjects, both sexes, age: ≥6 months and ≤10 years, with a confirmed diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis; * Written informed consent obtained from the participants and/or their parents/legal guardians. Exclusion Criteria: * Non-Caucasian ethnicity; age \< 6 or \> 10 years * Presence of other chronic conditions: hypereosinophilic syndrome, fungal or viral infections, connective tissue disorders, autoimmune diseases, vasculitis, bullous dermatoses (e.g., pemphigus), drug hypersensitivity reactions, graft-versus-host disease, monogenic disorders (e.g., Marfan syndrome type 2, Hyper-IgE syndrome) * Presence of scars, nevi, or unusual skin lesions on both forearms * Absence of written informed consent
Where this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.