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OpenTrials
Enrolling by Invitation

NCT Number: NCT07418489

Biotics Intervention Oriented to Rescue From Environmental Pollution Inflammatory Responses

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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Key information

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Turin - Department of Public Health and Pediatrics

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Dietary Supplement

The same capsules as aspect but without the pro-postbiotic formulation

Primary outcomes

  1. inflammatory markers

    Time frame: 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 outcomes

  1. PGE

    Time frame: From enrollment to the end of treatment at 16 weeks

    Change in urine platinum group elements

  2. OH-Pyr

    Time frame: From enrollment to the end of treatment at 16 weeks

    Change in urinary PAH biomarkers

  3. Comet

    Time frame: From enrollment to the end of treatment at 16 weeks

    Change in DNA damage in peripheral blood lymphocytes (comet assay)

  4. Microbiota

    Time frame: From enrollment to the end of treatment at 16 weeks

    Change in alfa and beta diversity of the gut microbiota composition and calprotectin assessment

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • SACCO s.r.l.

Registry information

Official study title

Effectiveness of a Blend Composed of Live and Inactivated Probiotic Microorganisms, Pro-post Blend, in Mitigating Early Biological Effects of Air Pollution in Healthy Subjects

Acronym: BIOREPAIR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.