Healthy 70 Street Market Vendors Working in Highly-polluted Areas of TurinBIOREPAIRNCT07418489
Biotics Intervention Oriented to Rescue From Environmental Pollution Inflammatory Responses
A study testing pro-postbiotic in people with Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin, run by University of Turin, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin
- What is being tested?
- pro-postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-27
- Street market vendor working ≥4 days/week (≥3 days at the same market site)
- Ability to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Turin - Department of Public Health and Pediatrics
Turin, 10126
About this study
Official 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
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.
Read more
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.
- Being tested
- pro-postbiotic, Placebo
- Keywords
- air pollution, probiotics, postbiotics, street vendors, oxidative stress, inflammation mitigation, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pro-postbioticDietary 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.
PlaceboDietary supplement
The same capsules as aspect but without the pro-postbiotic formulation
| Study group | Role | What they receive |
|---|---|---|
| Pro-postbiotic | Experimental | Participants assigned to the active group will receive a pro-postbiotic blend in capsule form for 16 weeks. Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (4)
PGE
Change in urine platinum group elements
Measured: From enrollment to the end of treatment at 16 weeks
OH-Pyr
Change in urinary PAH biomarkers
Measured: From enrollment to the end of treatment at 16 weeks
Comet
Change in DNA damage in peripheral blood lymphocytes (comet assay)
Measured: 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
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start24 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 70 Street Market Vendors Working in Highly-polluted Areas of TurinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- SACCO s.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418489
- Sponsor's protocol ID
- 0699075
- Acronym
- BIOREPAIR
- Status last verified
- Oct 2025
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07418489
- Acronym / sponsor ID
- BIOREPAIR / 0699075
- Keywords
- air pollution, probiotics, postbiotics, street vendors, oxidative stress, inflammation mitigation, microbiome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- SACCO s.r.l.
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pro-postbiotic | Experimental | Dietary Supplement: pro-postbioticParticipants assigned to the active group will receive a pro-postbiotic blend in capsule form for 16 weeks. |
| Control | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to the control group will receive a a placebo identical in appearance to the pro-postbiotic blend in capsule form for 16 weeks |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18-27
- Street market vendor working ≥4 days/week (≥3 days at the same market site)
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pro-postbioticThe 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 supplement | Pro-postbiotic |
| PlaceboThe same capsules as aspect but without the pro-postbiotic formulation | Dietary supplement | Control |
Primary outcome
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.
4 secondary outcomes
PGE
Time frame: From enrollment to the end of treatment at 16 weeks
OH-Pyr
Time frame: From enrollment to the end of treatment at 16 weeks
Comet
Time frame: From enrollment to the end of treatment at 16 weeks
Microbiota
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pro-postbiotic in people with Healthy 70 Street Market Vendors Working in Highly-polluted Areas of Turin, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory markers (time frame: From enrollment to the end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.