Biotics Intervention Oriented to Rescue From Environmental Pollution Inflammatory Responses (BIOREPAIR)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin
• Intervention / Treatment: Dietary supplement: pro-postbiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • University of Turin - Department of Public Health and Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pro-postbiotic; Participants assigned to the active group will receive a pro-postbiotic blend in capsule form for 16 weeks.	Dietary supplement: pro-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.
Placebo Comparator: Control; 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	Dietary supplement: Placebo; The same capsules as aspect but without the pro-postbiotic formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: SACCO s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: probiotics; oxidative stress; microbiome; air pollution; postbiotics; street vendors; inflammation mitigation
• Other Study ID Numbers: 0699075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No