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| Name | Class |
|---|---|
| Xiamen Yueyi Biotechnology Co., Ltd. | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics (Lactiplantibacillus plantarum PD01) | Dietary Supplement | The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides. |
| 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.). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruihua Dong | School of Public Health,Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health, Fudan University | Shanghai | Xuhui | 200030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2025 | Feb 10, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2025 | Feb 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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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.
| Placebo | Dietary Supplement | The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture. |
|
| 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 |
| D019602 |
| Food and Beverages |