Probiotics in Alleviating Microplastic-Induced Obesity

Probiotics in Alleviating Microplastic-Induced Obesity: A Randomized Double-Blind Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Intestinal Functional Disorder
• Intervention / Treatment: Dietary supplement: Probiotics (Lactiplantibacillus plantarum PD01); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China, 200030
      • School of public health, Fudan University

Participation Criteria

Eligibility Criteria

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

Description

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.

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: Probiotic intervention group; The Probiotic intervention agent includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water (below 40°C), and taken with meals or after meals.	Dietary supplement: Probiotics (Lactiplantibacillus plantarum PD01); The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides.
Placebo Comparator: Placebo control group; The Placebo control agent includes 2g Fructooligosaccharides. They should be taken three times a day, one pack at a time, brewed and dissolved in warm water (below 40°C), and taken with meals or after meals.	Dietary supplement: Placebo; The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microplastics (MPs) levels as assessed by Py-GC/MS	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.	Up to 2 months
Gut microbiota composition as assessed by Fecal Metagenomics	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.	Up to 2 months
Blood metabolic profiles as assessed by Blood Metabolomics	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.	Up to 2 months
Inflammatory cytokines and immune markers	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.	Up to 2 months
Blood biochemical indicators as assessed by the Mindray BS200 automatic biochemical analyzer	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.).	Up to 2 months
Routine blood examination (Five-part differential)	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.	Up to 2 months
Anthropometric and body composition indicators	To comply with reporting standards, these assessments are separated by unit: Weight: Measured in kilograms (kg). Height: Measured in centimeters (cm). BMI: Calculated as weight divided by height squared (kg/m^2). Circumferences: Waist and hip measurements reported in centimeters (cm). BIA Results: Body fat and muscle mass reported as a percentage of total body composition (%).	Up to 2 months

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Xiamen Yueyi Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Ruihua Dong, School of Public Health，Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): February 10, 2026

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 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: H2025029

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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