The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age

NCT ID: NCT06996327

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2026-01-10

Brief Summary

Atopic dermatitis (AD) is a common chronic inflammatory skin condition, primarily affecting children in urban and high-income areas. Its prevalence has increased significantly over the past 30 years, with up to 20% of children affected, often within their first year of life. AD is characterized by erythematous, scaly, pruritic lesions, xerosis, and frequent atopy, with distinct clinical features in children compared to adults.

The pathophysiology of AD involves skin barrier dysfunction, immune response alterations, and environmental triggers. Genetic factors, particularly mutations in the filaggrin gene, play a significant role in severe AD, leading to increased water loss and skin dehydration. Immunologically, a Th2-predominant response drives inflammation, and environmental exposures, such as air pollutants and irritants, exacerbate the condition.

Recent studies suggest that dietary habits, particularly a high intake of ultra-processed foods (UPFs), may contribute to AD by activating inflammatory pathways. UPFs, rich in advanced glycation end products (AGEs), induce oxidative stress and inflammation, potentially worsening skin damage. This study aims to explore the potential role of UPF-derived compounds, especially AGEs, in the pathogenesis of pediatric AD.

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients with AD

Pediatric patients with a confirmed diagnosis of atopic dermatitis

Evaluation of dietary consumption of UPFs

Intervention Type: OTHER

Evaluation of dietary consumption of ultraprocessed foods

Healthy controls

healthy controls matched for age and sex without atopic dermatitis

Evaluation of dietary consumption of UPFs

Intervention Type: OTHER

Evaluation of dietary consumption of ultraprocessed foods

Interventions

Evaluation of dietary consumption of UPFs

Evaluation of dietary consumption of ultraprocessed foods

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Roberto Berni Canani, MD, PhD

Role: primary

berni@unina.it

0817462680

Other Identifiers

163/2024

Identifier Type: -

Identifier Source: org_study_id