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

February 23, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Heavy metals [nickel (Ni), cobalt (Co), chromium (Cr), palladium, molybdenum, aluminium, and copper] are environmental contaminants able to impact on host cells of humans and various organisms, potentially causing serious damage. These metals can be present also in form of nanoparticles.

Nanoparticles are tiny particles between 1 and 100 nanometres in size. Nanoparticles have applications in a wide range of fields, including medicine, electronics, energy, and environmental remediation. However, the potential environmental and health risks associated with nanoparticles are also focus of global research.

The research on metal allergies in exposed subjects is challenging since the exposures are common both at the workplace and outside.

Environmental exposures are important for development of allergic contact dermatitis (ACD).

ACD is a common skin disorder caused by contact with an exogenous substance that elicits a hypersensitivity response in susceptible individuals.

Among workers exposed to such irritants and allergens at work, ACD is a common occupational health problem with a significant incidence. According to the most recent scientific studies, the overall prevalence of ACD between 1996 and 2019 is estimated at 10.5 per cent.

In some individuals, the ingestion of Ni-rich foods causes systemic skin disorders (urticaria/angioedema, erythema, eczema) and extracutaneous multi-organ symptoms (heartburn, meteorism, abdominal pain, alvo, oral aphthosis, headache, respiratory disorders, recurrent infections, fibromyalgia), expressed singularly or in variable association in some particularly sensitive subjects. This clinical picture is known as Systemic Nickel Allergy Syndrome (SNAS), which occurs in approximately 20% of ACD individuals.

Researchers will collect 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, and compare with ones obtained from healthy subjects to identify susceptibility / risk factors for these diseases.

Patients with systemic allergic syndrome (1st study group) and patients with ACD (2nd study group) will undergo the measurement of exposure to heavy metals and nanoparticles including Ni, Co, Cr, palladium, molybdenum, aluminium, and copper. Furthermore, putative effect biomarkers (patch test to metals, within-breath analysis of oscillometry parameters, and serum zonulin, related to cutaneous, respiratory, and gastro-intestinal exposure, respectively, and serum levels of protein oxidation products, as markers of systemic oxidative stress) and exposure biomarkers (serum and urinary metal concentrations) will be researched in both groups. The same investigation will be conducted on healthy subjects (3rd study group).

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40126
        • Not yet recruiting
        • Universita di Bologna
        • Contact:
        • Principal Investigator:
          • Pierpaolo Palumbo, PhD
        • Principal Investigator:
          • Lorenzo Chiari, Prof., PhD
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Sub-Investigator:
          • Riccardo Inchingolo, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela Rizzi, MD, PhD, MSc
        • Sub-Investigator:
          • Michele Centrone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allergic contact dermatitis to metals
Patients with allergic contact dermatitis due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
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.
Experimental: Systemic allergic syndromes to metals
Patients with systemic allergic syndrome due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
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.
Experimental: Healthy volunteers
Healthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentration of metals
Time Frame: At enrollment.
Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
At enrollment.
Urinary concentration of metals
Time Frame: At enrollment.
Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
At enrollment.
Patch test
Time Frame: At enrollment.

Application of patch test with heavy metals including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

Patch tests will be evaluated 48h and 72h after their application and will be evaluated through a universally accepted grading system elaborated by The International Contact Dermatitis Research Group. The intensity will be assessed according to the following criteria:

  1. ± faint, non-palpable erythema;
  2. + palpable erythema;
  3. ++ strong infiltrate, numerous papules, and vesicles present strong reaction;
  4. +++ coalescing vesicles, bullae or ulceration, and an extreme erythematous reaction.
At enrollment.
Number of subjects with altered values of respiratory system impedance
Time Frame: At enrollment.
All patients and healthy volunteers will undergo oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool to characterize peripheral airways dysfunction.
At enrollment.
Serum concentration of zonulin
Time Frame: At enrollment.
Measurement of serum zonulin.
At enrollment.
Serum concentration of protein oxidation products
Time Frame: At enrollment.
Measurement of serum protein oxidation products as markers of systemic oxidative stress.
At enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

University of Bologna

Investigators

  • Principal Investigator: Angela Rizzi, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6628 (Fred Hutchinson Cancer Research Center/UW Consortium)
  • PNC-PNRRDARE-PNC0000002 (Other Grant/Funding Number: Italian Ministry of University and Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Researchers intend to communicate the results of the trial to participants, healthcare professionals, and other relevant groups through scientific publications and national and international conference proceedings. No individual participant data will be shared.

All publications resulting from this research project will bear the following wording "PNC Notice DD n. 931 of 6/06/2022 - Project PNC0000002 - "DARE - Digital Lifelong Prevention".

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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