Probiotics in Alleviating Microplastic-Induced Obesity

NCT07416214 | Completed

• 1 other identifier: H2025029
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intestinal Functional Disorder; Inflammation

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Probiotic intervention group

EXPERIMENTAL

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)

Placebo control group

PLACEBO COMPARATOR

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

Interventions

Probiotics (Lactiplantibacillus plantarum PD01) DIETARY_SUPPLEMENT

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

Probiotic intervention group

Placebo DIETARY_SUPPLEMENT

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

Placebo control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Xiamen Yueyi Biotechnology Co., Ltd.: collaborator

Study Sites (1)

School of Public Health, Fudan University

Shanghai, Xuhui, 200030, China

Location

MeSH Terms

Conditions

Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ruihua Dong

  School of Public Health，Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The on-site implementation personnel and those responsible for coordinating the study only received the study number of the subjects, and were unaware of the intervention group allocation of the subjects. The subjects were also unaware of their intervention allocation. A copy of the sealed envelope of the non blinded study number for each subject is provided only to the study supervisor. Before the completion of data collection, the investigators and researchers kept the blind method for treatment allocation. All subjects were monitored in a double-blind way throughout the study period, and the subjects could not distinguish their own grouping by asking questions or from appearance and texture.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Random numbers were generated using IBM SPSS Statistics 26.0, with the random seed set to the date of the day. Eligible participants were sorted based on the size of the generated random numbers, with the first 50% of the ranked list assigned to the placebo group and the last 50% assigned to the intervention group. Participants were allocated randomly in equal proportions, and the random list was validated by a statistician.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: November 30, 2025
• Primary Completion: January 12, 2026
• Study Completion: February 10, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)