Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05976126 |
Other study ID # |
59 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 10, 2016 |
Est. completion date |
August 3, 2017 |
Study information
Verified date |
July 2023 |
Source |
Federico II University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
This study involved a screening of healthy adults from Campania region recruited in the human
biomonitoring study SPES (http://spes.campaniatrasparente.it), promoted by the Istituto
Zooprofilattico Sperimentale del Mezzogiorno (IZSM) of Portici (Italy) in collaboration with
the National Tumor Institute IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) "G.
Pascale" in Naples. Considering different source of environmental pressure (e.g., land use
and population density, presence of contaminated sites, quality of air, soil and water
bodies, closeness to waste management plants and illegal waste spills and fires), Pizzolante
and colleagues developed an integrated model to compute the Municipality Index of
Environmental Pressure (MIEP). The MIEP takes into account all factors involved in the
pollution processes, including the sources of contaminants and their migration pathways. The
MIEP enables the identification of 21 homogeneous sub-clusters, which include several
municipalities based on their environmental pressure scores. This categorization has resulted
in three macro-areas with increasing levels of impact pressure: LOW, MEDIUM and HIGH, as
described by Pierri and colleagues. In 2016, a total of 4,227 subjects were enrolled in the
SPES trial, considering healthy subjects living in several regional areas with different
environmental pressures. A subgroup of 359 subjects residing in the three impact areas was
randomly selected from the entire SPES cohort for gut microbiome analysis, in order to define
the impact of environmental pollution on gut microbial communities.