Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
NCT Number: NCT06529913
Acronym: MATRIOSKA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: 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
Interventions: DIAGNOSTIC_TEST: Collection of environmental, biological, and clinical data
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: University of Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 280
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Università di Bologna, Bologna, 40126, Italy|Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, 00168, Italy

Summary:
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).

Primary Outcome Measures: Serum concentration of metals, Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper., At enrollment.|Urinary concentration of metals, Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper., At enrollment.|Patch test, 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, 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, Measurement of serum zonulin., At enrollment.|Serum concentration of protein oxidation products, Measurement of serum protein oxidation products as markers of systemic oxidative stress., At enrollment.