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

Recruiting now · Not applicable

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT06529913

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

280

Starts

2025-01-13

Expected to finish

2026-12-31

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (enrolling)
• Università di Bologna — Bologna, Italy

Full record on ClinicalTrials.gov

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