Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases

Summary

The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects.

The main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group).

Participants will undergo:

* measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration.
* Patch test to before mentioned metals.
* Within-breath analysis of oscillometry parameters.
* Measurement of serum zonulin (related to gastro-intestinal exposure).
* Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).

Conditions

• Allergic Contact Dermatitis
• Metal Allergy
• Food Allergy
• Nickel Sensitivity
• Nickel; Eczema
• Aluminum Allergy
• Chromium; Eczema
• Functional Gastrointestinal Disorders
• Respiratory Injury
• Pollution; Exposure
• Pollution Related Respiratory Disorder
• Environmental Exposure
• Environment Related Disease
• Environmental Illness
• Oxidative Stress
• Risk Reduction

Interventions

DIAGNOSTIC_TEST

Collection of environmental, biological, and clinical data

All enrolled patients/healthy volunteers will undergo: * measurement of serum and urine concentration of metals (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper). * Patch test to metals. * Within-breath analysis of oscillometry parameters. * Measurement of serum zonulin. * Measurement of serum levels of protein oxidation products.

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Angela Rizzi, MD, PhD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-13

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Italy

Study Locations