Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06529913

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.

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

280

Participants Needed

2

Research Sites

13 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

This research aims to collect and compare environmental, biological, and clinical data from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes caused by exposure to heavy metals, nanoparticles, and emerging contaminants, as well as from healthy individuals. The study investigates whether these data differ between affected patients and healthy subjects by analyzing factors such as serum and urine metal concentrations, patch test results, respiratory parameters, and markers of oxidative stress and gut exposure. Participants are divided into three groups: those with systemic allergic syndrome related to metals, those with ACD due to metal exposure, and healthy volunteers without such exposure. All participants will undergo various assessments including measurement of serum and urine levels of metals like nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper. They will also have patch tests for these metals, within-breath oscillometry tests to assess respiratory function, and blood tests to measure serum zonulin and protein oxidation products. During the study, participants will be monitored through diagnostic tests performed at enrollment to evaluate metal exposure and biological responses. The main outcomes include serum and urinary metal concentrations, patch test results, respiratory impedance measures, and serum levels of zonulin and protein oxidation products. The study does not specify treatment but focuses on collecting data to understand susceptibility and risk factors. Participation involves a single assessment visit, with no long-term follow-up mentioned.

CONDITIONS

Brief 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...

  • Adults aged 18 years or older
  • Subjects with allergic contact dermatitis due to metal exposure
  • Subjects with systemic allergic syndrome due to metal exposure
  • Healthy adult volunteers
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Individuals under 18 years of age
  • Pregnant or breastfeeding women
  • Individuals with chronic renal failure requiring replacement treatment
  • Individuals with other systemic diseases related to metal exposure
  • Individuals with gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, or other skin diseases
  • Inability to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At enrollment

Participants undergo collection of environmental, biological, and clinical data including serum and urine metal concentrations, patch tests to metals, respiratory system impedance analysis, and measurements of serum zonulin and protein oxidation products.

1 visit (in-person)

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

M

Michele Centrone, MD

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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Frequently Asked Questions

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Published Research Related To This Trial

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https://pubmed.ncbi.nlm.nih.gov/37048784

Datterino Trial: A Double Blind, Randomized, Controlled, Crossover, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce in Systemic Nickel Allergy Syndrome.

Angela Rizzi, Raffaella Chini, Serena Porcari...

https://pubmed.ncbi.nlm.nih.gov/36143107

Diet Intervention Study through Telemedicine Assistance for Systemic Nickel Allergy Syndrome Patients during the COVID-19 Pandemic.

Eleonora Nucera, Angela Rizzi, Raffaella Chini...

https://pubmed.ncbi.nlm.nih.gov/34445054