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临床试验/NCT07418489
NCT07418489Enrolling By Invitation不适用

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

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年1月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
70
试验地点
1
主要终点
inflammatory markers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Chronic respiratory, cardiovascular, oncological, gastrointestinal, immunological or endocrine diseases
  • Pregnancy or breastfeeding
  • Alcohol or substance abuse
  • Use of immunosuppressants, antibiotics or antacids within the last 6 months
  • Known immunodeficiency

研究组 & 干预措施

Pro-postbiotic

Experimental

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

干预措施: pro-postbiotic (Dietary Supplement)

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

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

inflammatory markers

时间窗: 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.

次要结局

  • 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)
  • PGE(From enrollment to the end of treatment at 16 weeks)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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