Health TrialsbyHealthPanel

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

ConditionsAllergic Contact DermatitisMetal AllergyFood AllergyNickel SensitivityNickel; EczemaAluminum AllergyChromium; EczemaFunctional Gastrointestinal DisordersRespiratory InjuryPollution; ExposurePollution Related Respiratory DisorderEnvironmental ExposureEnvironment Related DiseaseEnvironmental IllnessOxidative StressRisk Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Allergic contact dermatitis to metalsExperimental treatment 1 intervention
Group B: Systemic allergic syndromes to metalsExperimental treatment 1 intervention
Group C: Healthy volunteersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum concentration of metals

Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

Time frame
At enrollment.
2

Urinary concentration of metals

Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.

Time frame
At enrollment.
3

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.

Time frame
At enrollment.
4

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.

Time frame
At enrollment.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

University of Bologna

Collaborator

Source ClinicalTrials.gov
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