Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin
Conditions
Keywords
air pollution, probiotics, postbiotics, street vendors, oxidative stress, inflammation mitigation, microbiome
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTpro-postbiotic
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.
DIETARY_SUPPLEMENTPlacebo
The same capsules as aspect but without the pro-postbiotic formulation
Sponsors
University of Turin, Italy
SACCO s.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18-27 * Street market vendor working ≥4 days/week (≥3 days at the same market site) * Ability to provide written informed consent
Exclusion criteria
* Chronic respiratory, cardiovascular, oncological, gastrointestinal, immunological or endocrine diseases * Smoking * Pregnancy or breastfeeding * Alcohol or substance abuse * Use of immunosuppressants, antibiotics or antacids within the last 6 months * Known immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory markers | From enrollment to the end of treatment at 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGE | From enrollment to the end of treatment at 16 weeks | Change in urine platinum group elements |
| OH-Pyr | From enrollment to the end of treatment at 16 weeks | Change in urinary PAH biomarkers |
| Comet | From enrollment to the end of treatment at 16 weeks | Change in DNA damage in peripheral blood lymphocytes (comet assay) |
| Microbiota | From enrollment to the end of treatment at 16 weeks | Change in alfa and beta diversity of the gut microbiota composition and calprotectin assessment |
Countries
Italy
Outcome results
None listed