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Completed

NCT Number: NCT07416214

Lactiplantibacillus Plantarum PD01 Supplementation Reduces Microplastics and Microplastic-associated Chemicals in Humans

The study attempts to conduct randomized double-blind controlled trials to understand whether daily exposure to microplastics (MPs) can cause potential impacts on human health, explore whether the intake of Lactiplantibacillus plantarum PD01 can alleviate potential obesity-related damages caused by MPs, and provide a scientific basis for the prevention and nutritional intervention of health hazards caused by MP exposure.

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Key information

Conditions

Intestinal Functional Disorder Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, Fudan University

Shanghai, Xuhui, 200030, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-65 years.
  • Body Mass Index (BMI) ≥ 24.0 kg/m² or meeting the criteria for central obesity (waist circumference ≥ 90 cm for men, ≥ 85 cm for women); participants with mild abnormalities in blood lipids and liver function indicators will be prioritized.
  • Permanent residents of the local area during the trial period, with no plans for long-term business trips or travel.
  • Fully understand the research content and voluntarily sign the informed consent form.

Exclusion criteria

  • Diagnosed congenital or acquired immunodeficiency diseases, severe allergic diseases, active gastrointestinal diseases, and other acute or chronic diseases requiring long-term treatment.
  • Use of antibiotics, immunosuppressants, probiotics, prebiotics, synbiotics, or other drugs that clearly affect gut microbiota or gastrointestinal function within the 6 months prior to the trial.
  • Regular intake of nutritional supplements (such as vitamins, fish oil, etc.) within the 6 months prior to the trial.
  • Having bad lifestyle habits such as smoking or alcoholism.
  • Women who are pregnant, lactating, or planning to become pregnant.
  • Weight change exceeding 5% of body weight within the 3 months prior to the trial.
  • Participation in or planning to participate in any other clinical intervention studies.

Treatment and study plan

Probiotics (Lactiplantibacillus plantarum PD01)

Dietary Supplement

The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides.

Placebo

Dietary Supplement

The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture.

Primary outcomes

  1. Fecal microplastics (MPs) levels as assessed by Py-GC/MS

    Time frame: Up to 2 months

    Py-GC/MS method for detecting microplastic (MPs) levels in feces of research subjects. The analysis includes 11 types of plastics: PC, PE, PP, PS, PA6, PET, PLA, PVC, PA66, PBAT, and PMMA. The concentration of fecal microplastics will be reported in units of μg/g dry weight.

  2. Measurement of Urinary PAE Metabolites Using UHPLC-MS/MS

    Time frame: 1 Week

    Urine samples were stored at -80 ℃ until analysis of urinary creatinine and PAEs concentrations. The urinary PAE metabolites were chromatographically separated on an Agilent Eclipse Plus C18 RRHD column (2.1 × 100 mm, 1.8 μm), and quantified using an SCIEX ExionLC AD ultra-high-performance liquid chromatography system coupled with an AB SCIEX 7500+ triple quadrupole mass spectrometer.

  3. Gut microbiota composition as assessed by Fecal Metagenomics

    Time frame: Up to 2 months

    Fecal DNA is extracted and subjected to high-throughput sequencing to analyze the diversity, abundance, and functional genes of the gut microbiota. The analysis aims to observe changes in the microbial community structure following the intervention.

  4. Blood metabolic profiles as assessed by Blood Metabolomics

    Time frame: Up to 2 months

    Untargeted metabolomics analysis is performed on blood samples to identify alterations in metabolic pathways and metabolite profiles associated with the intervention. Data will be processed to match metabolites with standard databases.

  5. Inflammatory cytokines and immune markers

    Time frame: Up to 2 months

    Serum levels of inflammatory and immune markers are detected, including Monocyte Chemoattractant Protein-1 (MCP-1), Interleukin-1β (IL-1β), Interleukin-6 (IL-6), Tumor Necrosis Factor-α (TNF-α), P-selectin, C-reactive protein (CRP), and Fibrinogen.

  6. Blood biochemical indicators as assessed by the Mindray BS200 automatic biochemical analyzer

    Time frame: Up to 2 months

    Serum samples are processed using a Thermo Scientific Sorvall ST 40 centrifuge (3000 rpm, 4°C, 5 min). The supernatant is collected and analyzed using the Mindray BS200 automatic biochemical analyzer. Parameters include liver function indicators and blood lipid indicators (Total Cholesterol, Triglycerides, HDL, LDL, etc.).

  7. Routine blood examination (Five-part differential)

    Time frame: Up to 2 months

    Routine blood examination is performed to assess the white blood cell count (WBC) and a five-part differential count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils). Results are reported in standard clinical units.

  8. Body composition measured by using InBody770

    Time frame: Up to 2 months

    Body composition was analyzed using multi-frequency bioelectrical impedance analysis with the InBody770 body composition analyzer. The measurements included body fat percentage, skeletal muscle mass, and visceral fat area. All measurements were taken while the participants were fasting and after emptying their bladders.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Xiamen Yueyi Biotechnology Co., Ltd.

Registry information

Official study title

Lactiplantibacillus Plantarum PD01 Supplementation Reduces Microplastics and Microplastic-associated Chemicals in Humans: A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Aug 17, 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.

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