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Recruiting NCT06996327

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

Observational Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluation of dietary consumption of UPFs.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: 6 months — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project

Overview

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.

Interventions

  • Other Evaluation of dietary consumption of UPFs
    Evaluation of dietary consumption of ultraprocessed foods

Primary outcome measures

  • Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs) [Time frame: First year]
Secondary outcome measures (5)
  • Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs) [Time frame: First year]
  • Assessment of skin AGEs accumulation level [Time frame: First year]
  • Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes [Time frame: Second year]
  • Effects of AGEs intake on SCORAD/EASI scores [Time frame: First year]
  • Evaluation of transepidermal water loss (TEWL) [Time frame: First year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • Department of Traslational Medical Science - University of Naples Federico II — Naples

Identifiers

NCT: NCT06996327 · 163/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗