RecruitingNot ApplicableNCT06529913

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

Model of diseAses Related to Environmental Exposure to Heavy meTals, nanopaRticles and Emergent Contaminants, Using a dIgital platfOrm of Clinical and Bio-humoral Data: the Way to Susceptibility/RisK BiomArker [MATRIOSKA Study] - The Seed.


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

280 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • adult subjects (over 18 years of age).
  • Subjects suffering from allergic contact dermatitis due to metals.
  • Subjects with systemic allergic syndrome due to metals.
  • Adult healthy subjects.
  • Subjects able to give written informed consent.

Exclusion Criteria6

  • Subjects under the age of 18years.
  • Pregnant/breastfeeding women.
  • Subjects suffering from chronic renal failure requiring replacement treatment.
  • Subjects suffering from other systemic pathologies related to exposure to metals.
  • Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.
  • Subjects unable to express written informed consent.

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Interventions

DIAGNOSTIC_TESTCollection 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.


Locations(2)

Università di Bologna

Bologna, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT06529913


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