NCT06529913Recruiting
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.
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- Jan 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06529913
What you commit to
- Study type: Interventional
- Planned participants: 280
- From Jan 2025 to the primary completion date, Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects suffering from chronic renal failure requiring replacement treatment.
- Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.
Age
- Subjects under the age of 18years.
Other
- Pregnant/breastfeeding women.
- Subjects suffering from other systemic pathologies related to exposure to metals.
- Subjects unable to express written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universita di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.