Emerging Role of Alarmins in Food Allergy: An Update on Pathophysiological Insights, Potential Use as Disease Biomarkers, and Therapeutic Implications.
Angela Rizzi, Elena Lo Presti, Raffaella Chini...
https://pubmed.ncbi.nlm.nih.gov/37048784Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-24
280
Participants Needed
2
Research Sites
13 weeks
Total Duration
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
U
University of Bologna
Collaborating Sponsor
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
Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
A
Angela Rizzi, MD, PhD
M
Michele Centrone, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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