Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06529913

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-24

280

Participants Needed

2

Research Sites

102 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

U

University of Bologna

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Subjects under the age of 18 years
  • Pregnant or 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, or other skin diseases
  • Subjects unable to express written informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Università di Bologna

Bologna, Italy, 40126

Not Yet Recruiting

2

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

A

Angela Rizzi, MD, PhD

CONTACT

M

Michele Centrone, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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