Environmental-Pollution-Related ConditionSPESNCT05976126
Characterization of a Population Living in Highly Contaminated Settlement in Campania Region
An observational study of Environmental-Pollution-Related Condition, run by Francesca De Filippis.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental-Pollution-Related Condition
- What is being tested?
- Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements
- How many people
- 4,227 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2016to 3 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- healthy subjects (no severe, chronic or neoplastic conditions)
- 20-50 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)
Who cannot join
- age < 20 and > 50 years at enrollment
- severe, chronic or neoplastic conditions
- viral infections (HIV, HCV, HBV)
- use of drugs or alcohol
- obesity
About this study
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.
Read the detailed 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.
- Being tested
- Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements
- Keywords
- dioxins, persistent organic pollutants, heavy metals, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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).] Receives: 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).] Receives: 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).] Receives: Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: at enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start10 Sep 2016
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental-Pollution-Related ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesca De Filippis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesca De Filippis, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976126
- Sponsor's protocol ID
- 59
- Acronym
- SPES
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38802370
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Population Living in Highly Contaminated Settlement in Campania Region
- ClinicalTrials.gov ID
- NCT05976126
- Acronym / sponsor ID
- SPES / 59
- Keywords
- dioxins, persistent organic pollutants, heavy metals, gut microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,227 participants (actual)
- Lead sponsor
- Francesca De FilippisUniversity, hospital or other
- Study start
- 10 Sep 2016 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High environmental pollution group (HIGH) | – | Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elementssubjects 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).] |
| Medium environmental pollution group (MEDIUM) | – | Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elementssubjects 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).] |
| Low environmental pollution group (LOW) | – | Other: Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elementssubjects 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).] |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (8 listed)
- healthy subjects (no severe, chronic or neoplastic conditions)
- 20-50 years old
- both sexes
- no important viral infection (HIV, HCV, HBV)
- no use of drugs
Key exclusion criteria (5 listed)
- age < 20 and > 50 years at enrollment
- severe, chronic or neoplastic conditions
- viral infections (HIV, HCV, HBV)
- use of drugs or alcohol
- obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of dioxins (PCDD/Fs), polychlorinated biphenyls (PCBs) and trace elementsPeripheral 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. | Other | High environmental pollution group (HIGH), Low environmental pollution group (LOW), Medium environmental pollution group (MEDIUM) |
Primary outcome
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
Time frame: at enrollement
measure of PCDD/Fs and PCBs in human blood serum using High-Resolution Gas Chromathography coupled to High-Resolution Mass Spectrometry (HRGC-HRMS) analysis
Comparison of plasmatic concentration of trace elements in subjects from high, medium and low pollution area as assessed by ICP-MS
Time frame: at enrollement
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)
Comparison of gut microbiome composition and functions in subjects from high, medium and low pollution area as assessed by metagenomics
Time frame: at enrollement
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 38802370De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental-Pollution-Related Condition, run by Francesca De Filippis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: at enrollement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.