Biotics Intervention Oriented to Rescue From Environmental Pollution Inflammatory Responses

NCT07418489 | Enrolling By Invitation

• 1 other identifier: 0699075
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin

Keywords

air pollution; probiotics; postbiotics; street vendors; oxidative stress; inflammation mitigation; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PGE

  From enrollment to the end of treatment at 16 weeks

• OH-Pyr

  From enrollment to the end of treatment at 16 weeks

• Comet

  From enrollment to the end of treatment at 16 weeks

• Microbiota

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

Pro-postbiotic

EXPERIMENTAL

Participants assigned to the active group will receive a pro-postbiotic blend in capsule form for 16 weeks.

Dietary Supplement: pro-postbiotic

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

Dietary Supplement: Placebo

Interventions

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.

Pro-postbiotic

Placebo DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18-27
• Street market vendor working ≥4 days/week (≥3 days at the same market site)
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• SACCO s.r.l.: collaborator

Study Sites (1)

University of Turin - Department of Public Health and Pediatrics

Turin, 10126, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: January 24, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)