Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529913
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Environmental Exposure to Heavy Metals Nanoparticles and Emergent Contaminants and Risk of Allergic Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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 SusceptibilityRisK BiomArker MATRIOSKA Study - The Seed
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATRIOSKA
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
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
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 105 per cent
In some individuals the ingestion of Ni-rich foods causes systemic skin disorders urticariaangioedema 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
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 105 per cent
In some individuals the ingestion of Ni-rich foods causes systemic skin disorders urticariaangioedema 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None