Intestinal Functional DisorderNCT07416214
Lactiplantibacillus Plantarum PD01 Supplementation Reduces Microplastics and Microplastic-associated Chemicals in Humans
A study testing Probiotics (Lactiplantibacillus plantarum PD01) in people with Intestinal Functional Disorder and Inflammation, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Functional Disorder, Inflammation
- What is being tested?
- Probiotics (Lactiplantibacillus plantarum PD01)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactiplantibacillus Plantarum PD01 Supplementation Reduces Microplastics and Microplastic-associated Chemicals in Humans: A Randomized, Double-blind, Placebo-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.
- Conditions
- Intestinal Functional Disorder, Inflammation
- Being tested
- Probiotics (Lactiplantibacillus plantarum PD01), Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (Lactiplantibacillus plantarum PD01)Dietary supplement
The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides.
PlaceboDietary supplement
The placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
Measurement of Urinary PAE Metabolites Using UHPLC-MS/MS
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.
Measured: 1 Week
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.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 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.
Measured: Up to 2 months
Body composition measured by using InBody770
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start30 Nov 2025
- Primary completion12 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Functional DisorderStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Yueyi Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Ruihua Dong, Fudan University
- Investigators
- Ruihua Dong, Principal investigator, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416214
- Sponsor's protocol ID
- H2025029
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactiplantibacillus Plantarum PD01 Supplementation Reduces Microplastics and Microplastic-associated Chemicals in Humans: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07416214
- Acronym / sponsor ID
- H2025029
- Conditions
- Intestinal Functional Disorder, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Xiamen Yueyi Biotechnology Co., Ltd.
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic intervention group | Experimental | Dietary Supplement: Probiotics (Lactiplantibacillus plantarum PD01)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 | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (Lactiplantibacillus plantarum PD01)The probiotic supplement includes 0.2g Lactiplantibacillus plantarum FABYIO PD01 (containing 10 billion CFU) and 1.8g Fructooligosaccharides. | Dietary supplement | Probiotic intervention group |
| PlaceboThe placebo includes 2.0g Fructooligosaccharides with an indistinguishable appearance and texture. | Dietary supplement | Placebo control group |
Primary outcome
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.
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.
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.
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.
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.
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.).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruihua Dong principal investigator
School of Public Health，Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (Lactiplantibacillus plantarum PD01) in people with Intestinal Functional Disorder and Inflammation, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microplastics (MPs) levels as assessed by Py-GC/MS (time frame: Up to 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.