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| Name | Class |
|---|---|
| SACCO s.r.l. | UNKNOWN |
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Improving air quality in urban areas represents a major public health challenge. In regions such as the Po Valley, airborne particulate matter (PM₁₀ and PM₂.₅) concentrations frequently exceed World Health Organization limits, contributing to an increased incidence of respiratory, cardiovascular, and also gastrointestinal diseases.
Fine particulate matter can carry toxic compounds, including polycyclic aromatic hydrocarbons such as 1-nitropyrene (1-NP) and platinum group elements (PGE) released from catalytic converter abrasion. Due to their small size, these particles can penetrate the respiratory and gastrointestinal tracts, triggering pro-inflammatory responses and oxidative stress.
This study aims to evaluate whether a probiotic dietary supplement (pro-post blend) can mitigate air-pollution-induced inflammatory responses in healthy subjects by enhancing intestinal barrier function and modulating the gut-lung axis. The study is designed as a randomised, placebo-controlled interventional trial lasting 20 months (October 2025-June 2027, with the start of participant sampling scheduled for September 2026), involving 70 street market vendors working in highly-polluted areas of Turin.
Participants will undergo pre- and post-intervention assessments, including the measurement of plasma inflammatory markers (e.g. CRP, IL-6, IL-8, IL-1β, TNF-α, IFN-γ), blood PGE levels, urinary biomarkers of diesel exposure, DNA damage in peripheral lymphocytes assessed by the comet assay, and metagenomic analysis of the gut microbiome. Evaluations will be performed at baseline (T0), after 2 months (T1, medical follow-up only), 4 months of continuous daily supplementation (T2), and 2 months after treatment discontinuation (T3, medical follow-up only).
Overall, this study aims to provide experimental evidence on the potential protective role of a pro-postbiotic formulation against the adverse biological effects of air pollution, supporting the development of a complementary preventive strategy that complement emission-reduction policies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro-postbiotic | Experimental | Participants assigned to the active group will receive a pro-postbiotic blend in capsule form for 16 weeks. |
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| Control | Placebo Comparator | Participants assigned to the control group will receive a a placebo identical in appearance to the pro-postbiotic blend in capsule form for 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pro-postbiotic | Dietary Supplement | The blend consists of three viable lactic acid bacteria strains, Lactiplantibacillus plantarum (IMC 509), Lacticaseibacillus casei (BGP 93), and Lacticaseibacillus paracasei (BGP 1), combined with Bifidobacterium animalis subsp. lactis (BLC1) in heat-inactivated form. All species included in the blend are listed under the EFSA Qualified Presumption of Safety (QPS) framework. Each viable strain is present at a minimum concentration of 10⁹ cells per daily dose. |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory markers | Change in serum inflammatory markers (CRP, IL-6, IL-8, IL-1β, TNF-α, IFN-γ) from baseline (T0) to the end of treatment (T2) in the intervention group versus placebo. | From enrollment to the end of treatment at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PGE | Change in urine platinum group elements | From enrollment to the end of treatment at 16 weeks |
| OH-Pyr | Change in urinary PAH biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin - Department of Public Health and Pediatrics | Turin | 10126 | Italy |
Data will be securely stored on local servers within the University of Turin. Microbiome sequencing data will be transferred in anonymised form to the Illumina BaseSpace cloud platform (Frankfurt, Germany). Individual participant data will be managed using the MEDCap platform. All procedures comply with European and Italian legislation, as well as with internal policies of the University of Turin.
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Participants will undergo pre- and post-intervention assessments, including the measurement of plasma inflammatory markers (e.g. CRP, IL-6, IL-8, IL-1β, TNF-α, IFN-γ), blood PGE levels, urinary biomarkers of diesel exposure, DNA damage in peripheral lymphocytes assessed by the comet assay, and metagenomic analysis of the gut microbiome. Evaluations will be performed at baseline (T0), after 2 months (T1, medical follow-up only), 4 months of continuous daily supplementation (T2), and 2 months after treatment discontinuation (T3, medical follow-up only).
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| Placebo | Dietary Supplement | The same capsules as aspect but without the pro-postbiotic formulation |
|
| From enrollment to the end of treatment at 16 weeks |
| Comet | Change in DNA damage in peripheral blood lymphocytes (comet assay) | From enrollment to the end of treatment at 16 weeks |
| Microbiota | Change in alfa and beta diversity of the gut microbiota composition and calprotectin assessment | From enrollment to the end of treatment at 16 weeks |