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

NCT06529913 | Recruiting

• 2 other identifiers: 6628PNC-PNRRDARE-PNC0000002
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief 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).

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

Keywords

Metal Allergy; Nanoparticles; Emergent contaminants; Nickel; Aluminium; Copper; Chromium; Cobalt; Palladium; Titanium; Allergic Contact Dermatitis; Food Allergy; Functional Gastrointestinal Disorders; Respiratory Injury; Environmental Exposure; Patch test; Biomarkers

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (3)

Allergic contact dermatitis to metals

EXPERIMENTAL

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

Systemic allergic syndromes to metals

EXPERIMENTAL

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

Healthy volunteers

EXPERIMENTAL

Healthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).

Diagnostic Test: Collection of environmental, biological, and clinical data

Interventions

Collection of environmental, biological, and clinical data DIAGNOSTIC_TEST

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.

Allergic contact dermatitis to metals; Healthy volunteers; Systemic allergic syndromes to metals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• University of Bologna: collaborator

Study Sites (2)

Università di Bologna

Bologna, 40126, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (9)

• Rizzi A, Lo Presti E, Chini R, Gammeri L, Inchingolo R, Lohmeyer FM, Nucera E, Gangemi S. Emerging Role of Alarmins in Food Allergy: An Update on Pathophysiological Insights, Potential Use as Disease Biomarkers, and Therapeutic Implications. J Clin Med. 2023 Apr 4;12(7):2699. doi: 10.3390/jcm12072699.

  PMID: 37048784 BACKGROUND

• Rizzi A, Chini R, Porcari S, Settanni CR, Persichetti E, Mora V, Fanali C, Leonetti A, Parrinello G, Lohmeyer FM, Inchingolo R, Mele MC, Gasbarrini A, Nucera E. Datterino Trial: A Double Blind, Randomized, Controlled, Crossover, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce in Systemic Nickel Allergy Syndrome. J Clin Med. 2022 Sep 16;11(18):5459. doi: 10.3390/jcm11185459.

  PMID: 36143107 BACKGROUND

• Nucera E, Rizzi A, Chini R, Giangrossi S, Lohmeyer FM, Parrinello G, Musca T, Miggiano GAD, Gasbarrini A, Inchingolo R. Diet Intervention Study through Telemedicine Assistance for Systemic Nickel Allergy Syndrome Patients during the COVID-19 Pandemic. Nutrients. 2021 Aug 23;13(8):2897. doi: 10.3390/nu13082897.

  PMID: 34445054 BACKGROUND

• Rizzi A, Chini R, Inchingolo R, Carusi V, Pandolfi F, Gasbarrini A, Nucera E. Nickel allergy in lipid transfer protein sensitized patients: Prevalence and clinical features. Int J Immunopathol Pharmacol. 2020 Jan-Dec;34:2058738420974895. doi: 10.1177/2058738420974895.

  PMID: 33242297 BACKGROUND

• Rizzi A, Di Rienzo A, Buonomo A, Aruanno A, Carusi V, Ricci AG, Centrone M, Mezzacappa S, Romeo L, Schiavino D, Inchingolo R, Gasbarrini A, Nucera E. Impact of nickel oral hyposensitization on quality of life in systemic nickel allergy syndrome. Int J Immunopathol Pharmacol. 2020 Jan-Dec;34:2058738420934629. doi: 10.1177/2058738420934629.

  PMID: 32567420 BACKGROUND

• Rizzi A, Nucera E, Laterza L, Gaetani E, Valenza V, Corbo GM, Inchingolo R, Buonomo A, Schiavino D, Gasbarrini A. Irritable Bowel Syndrome and Nickel Allergy: What Is the Role of the Low Nickel Diet? J Neurogastroenterol Motil. 2017 Jan 30;23(1):101-108. doi: 10.5056/jnm16027.

  PMID: 28049864 BACKGROUND

• Campanale M, Nucera E, Ojetti V, Cesario V, Di Rienzo TA, D'Angelo G, Pecere S, Barbaro F, Gigante G, De Pasquale T, Rizzi A, Cammarota G, Schiavino D, Franceschi F, Gasbarrini A. Nickel free-diet enhances the Helicobacter pylori eradication rate: a pilot study. Dig Dis Sci. 2014 Aug;59(8):1851-5. doi: 10.1007/s10620-014-3060-3. Epub 2014 Mar 5.

  PMID: 24595654 BACKGROUND

• Patriarca G, Schiavino D, Pecora V, Lombardo C, Pollastrini E, Aruanno A, Sabato V, Colagiovanni A, Rizzi A, De Pasquale T, Roncallo C, Decinti M, Musumeci S, Gasbarrini G, Buonomo A, Nucera E. Food allergy and food intolerance: diagnosis and treatment. Intern Emerg Med. 2009 Feb;4(1):11-24. doi: 10.1007/s11739-008-0183-6. Epub 2008 Aug 16.

  PMID: 18709496 BACKGROUND

• Veneroni C, Gobbi A, Pompilio PP, Dellaca R, Fasola S, La Grutta S, Leyva A, Porszasz J, Stornelli SR, Fuso L, Valach C, Breyer-Kohansal R, Breyer MK, Hartl S, Contu C, Inchingolo R, Hodgdon K, Kaminsky DA. Reference Equations for Within-Breath Respiratory Oscillometry in White Adults. Respiration. 2024;103(9):521-534. doi: 10.1159/000539532. Epub 2024 Jun 7.

  PMID: 38843786 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Food Hypersensitivity; Eczema; Gastrointestinal Diseases; Environmental Illness; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Digestive System Diseases; Disorders of Environmental Origin; Behavior

Study Officials

• Angela Rizzi, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Rizzi, MD, PhD

CONTACT

+390630154952; angela.rizzi@policlinicogemelli.it

Michele Centrone, MD

CONTACT

+390630154952; michele.centrone@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)