Characterization of a Population Living in Highly Contaminated Settlement in Campania Region

NCT05976126 | Completed

• 1 other identifier: 59
• Study Type: observational
• Target: 4,227
• Locations: 0 countries
• Sites: N/A

Brief Summary

some areas in the Campania region (southern Italy) have attracted media coverage in the past 15 years, and are considered a dramatic example of an extremely polluted area. The environmental pollution issue has become a significant concern in the Campania Region as a result of the "waste management crisis" that mainly affects the northern part of the region, encompassing 91 municipalities. As a consequence, in the last few decades, a large rural area between the provinces of Naples and Caserta, primarily used for agriculture and livestock breeding, was considered to be at high risk of contamination due to the illegal disposal of urban and industrial waste. In these landfills, a broad range of hazardous wastes from different parts of Italy has been found. In addition, the wastes have often been open-air burned, leading to this area being named the "Land of Fires". Senior and Mazza first highlighted the high incidence of cancer deaths in a specific area of the Campania region (compared to regional and national rates), which was identified by the authors as the "triangle of death". Afterwards, several studies reported a link between illegal waste disposal and an increased risk of cancer for the population, potentially associated with human exposure to carcinogenic substances such as dioxins, dioxin-like compounds, or polycyclic aromatic hydrocarbons, which can be released into air, soil, and water bodies through the illegal dumping and burning of waste. Within this study, 4,227 subjects were enrolled in the SPES trial, considering healthy subjects living in several regional areas with different environmental pressures. Blood dioxins and heavy metals were analyzed. Gut microbiome was analyzed on a subset of 359 subjects from the three different exposure area.

Conditions

Environmental-Pollution-Related Condition

Keywords

dioxins; persistent organic pollutants; heavy metals; gut microbiome

Outcome Measures

Primary Outcomes (3)

• Comparison of plasmatic concentration of dioxins (PCDD/Fs) and polychlorinated biphenyls (PCBs) in subjects from high, medium and low pollution area as assessed by HRGC-HRMS

  measure of PCDD/Fs and PCBs in human blood serum using High-Resolution Gas Chromathography coupled to High-Resolution Mass Spectrometry (HRGC-HRMS) analysis

  at enrollement

• Comparison of plasmatic concentration of trace elements in subjects from high, medium and low pollution area as assessed by ICP-MS

  trace elements (arsenic, beryllium, cadmium, cobalt, chromium, copper, iron, mercury, lithium, manganese, molybdenum, nickel, lead, antimony, selenium, strontium, thallium, vanadium, and zinc) were determined in human plasma using an inductively coupled plasma mass spectrometer (ICP-MS)

  at enrollement

• Comparison of gut microbiome composition and functions in subjects from high, medium and low pollution area as assessed by metagenomics

  Microbiome composition and potential functions was determined by shotgun metagenomics (Illumina paired-end sequencing, 2x150bp). The massive amount of sequences obtained was analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species and genes occurring in each sample was determined.

  at enrollement

Study Arms (3)

High environmental pollution group (HIGH)

subjects living in area characterized by high environmental pollution, as defined by Pizzolante et al. \[Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).\]

Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements

Medium environmental pollution group (MEDIUM)

subjects living in area characterized by medium environmental pollution, as defined by Pizzolante et al. \[Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).\]

Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements

Low environmental pollution group (LOW)

subjects living in area characterized by low environmental pollution, as defined by Pizzolante et al. \[Development of a municipality index of environmental pressure in Campania, Italy. Future Sci. OA 7(7), FSO720 (2021).\]

Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements

Interventions

Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements OTHER

Peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the early morning, in blood collection tubes (SST II Advance Tubes, BD Vacutainer). The samples were left for approximately 50 min, then the serum was separated from whole blood by centrifugation at 2,000 rcf for 10 min at 4 °C and then aliquots were stored at -80°C until analysis.

High environmental pollution group (HIGH); Low environmental pollution group (LOW); Medium environmental pollution group (MEDIUM)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults (20-50 years/old) resident in one of the municipalities under study for at least 5 years (Campania Region, Italy) grouped according to the environmental impact (high, medium and low) (as reported in http://www.campaniatrasparente.it)

You may qualify if:

• healthy subjects (no severe, chronic or neoplastic conditions)
• years old
• both sexes
• no important viral infection (HIV, HCV, HBV)
• no use of drugs
• no alcohol abuse
• no obesity of II, III and IV classes.
• resident in one of the municipalities under study for at least 5 years (Campania Region, Italy)

You may not qualify if:

• age \< 20 and \> 50 years at enrollment
• severe, chronic or neoplastic conditions
• viral infections (HIV, HCV, HBV)
• use of drugs or alcohol
• obesity

Sponsors & Collaborators

• Francesca De Filippis: lead

Related Publications (1)

• De Filippis F, Valentino V, Sequino G, Borriello G, Riccardi MG, Pierri B, Cerino P, Pizzolante A, Pasolli E, Esposito M, Limone A, Ercolini D. Exposure to environmental pollutants selects for xenobiotic-degrading functions in the human gut microbiome. Nat Commun. 2024 May 27;15(1):4482. doi: 10.1038/s41467-024-48739-7.

  PMID: 38802370 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples were self-collected and frozen at -80°C for microbial DNA extraction; peripheral blood (about 100 mL in several aliquots) was collected from the volunteers, in the early morning, in blood collection tubes

MeSH Terms

Interventions

Polychlorinated Biphenyls; Trace Elements

Intervention Hierarchy (Ancestors)

Dioxins and Dioxin-like Compounds; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 4, 2023
• Study Start: September 10, 2016
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: August 4, 2023

Record last verified: 2023-07