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

NCT06996327 | Recruiting

• 1 other identifier: 163/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs)

  Comparative evaluation of dietary consumption of UPFs in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex

  First year

Secondary Outcomes (5)

• Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)

  First year

• Assessment of skin AGEs accumulation level

  First year

• Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes

  Second year

• Effects of AGEs intake on SCORAD/EASI scores

  First year

• Evaluation of transepidermal water loss (TEWL)

  First year

Study Arms (2)

Pediatric patients with AD

Pediatric patients with a confirmed diagnosis of atopic dermatitis

Other: Evaluation of dietary consumption of UPFs

Healthy controls

healthy controls matched for age and sex without atopic dermatitis

Other: Evaluation of dietary consumption of UPFs

Interventions

Evaluation of dietary consumption of UPFs OTHER

Evaluation of dietary consumption of ultraprocessed foods

Healthy controls; Pediatric patients with AD

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian subjects of both sexes, aged ≥6 and ≤10 years, with a diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis, recruited from the Pediatric Outpatient Clinics of the University Hospital "Federico II".

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: January 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

IT (1)