CirrhosisNCT07280390
Microplastics, Cirrhosis and Portal Hypertension
An observational study of Cirrhosis and Microplastics, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Microplastics, Portal Hypertension Related to Cirrhosis
- What is being tested?
- Assessment of microplastics in tissue
- How many people
- 30 participants
- Where
- 2 sitesIndia
- Study dates
- 1 May 2026to 25 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhosis Healthy liver control tissue will be taken from autopsy patients with consent
Who may be able to join
- Age range of 18-70 years
- Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.
- Undergoing elective surgery or liver transplantation
Who cannot join
- • Hepatocellular carcinoma
- Pregnancy or lactation
- Patients with HIV or retroviral therapy
- Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Dr. Madhumita Premkumar
Chandigarh, Chandigarh, 160012
Dr. Madhumita Premkumar, MD, +919540951061, drmadhumitap@gmail.com
- Recruiting
PGIMER Chandigarh
Chandigarh, Chandigarh, 160012
Prerna Premkumar, 01722754777, drmadhumitap@gmail.com
drmadhumitap@gmail.com
About this study
Official title: The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India
Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension.
Globally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health.
Read more
Polystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity.
The study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.
Read the detailed description
First, because the methodology requires chemical digestion, it is unclear where in the liver MPs are deposited. For instance, it is indeterminate if MPs are deposited intracellularly, in Kupffer cells, endothelium or hepatocytes/cholangiocytes. In the present study histopathological assessments of the liver tissue will be performed to determine the presence of the MPs.
- Furthermore, the study will assess various polymer types of MP in cirrhotic liver tissue including commonly observed plastic polymers PS (polystyrene), PE (polyethylene), PP (polypropylene), PVC (polyvinyl chloride), PET (polyethylene terephthalate), PC (polycarbonate), and PMMA (polymethyl methacrylate).
- Therefore, potential cellular sites of deposition in the liver will be assessed. If the MPs were in the systemic circulation, without any liver parenchymal residues, such particles should also be identified in spleen and kidney samples.
- histopathology and electron microscopy of the liver tissue which should clarify the specific accumulation sites.
- Conditions
- Cirrhosis, Microplastics, Portal Hypertension Related to Cirrhosis, Nanoplastics, Pollution, Cirrhosis and Chronic Liver Disease
- Being tested
- Assessment of microplastics in tissue
- Keywords
- Microplastics, Nanoplastics, Plastic pollution, Cirrhosis, Portal hypertension
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of microplastics in tissueDiagnostic test
After meeting inclusion and exclusion criteria, 30 patients with cirrhosis will be included in this study with written informed consent from patient (surgical cases) or scheduled liver biopsy. Diagnosis of chronic liver disease will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy as recorded in the patient file, imaging studies (ultrasonography and doppler of splenoportal venous axis). Underlying etiology of liver disease will be recorded. Complications of cirrhosis like hepatorenal syndrome (HRS), spontaneous bacterial peritonitis (SBP), upper gastrointestinal bleed, hepatic encephalopathy, acute kidney injury will be recorded from the patient's casefile.
Tissue Sample Processing Standard laboratory solvents (i.e., acetonitrile, methanol, and water (LiChrosolv and SupraSolv grade) will be procured. The contact of laboratory surfaces and equipment will be minimized to reduce the risk of background contamination by plastics.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cirrhosis | Cirrhosis and Portal Hypertension who are getting elective surgery or liver transplantation Receives: Diagnostic Test: Assessment of microplastics in tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to assess MPs in human liver tissue, analysing their morphology, size, and composition (4-30 µm) in tissue samples from the liver inpatients with cirrhosis as compared with controls without cirrhosis
MPs in liver cirrhosis
Measured: At time of enrolment
Secondary outcomes (3)
• Identification of Various polymer types, including PS, PVC, PET, PMMA, POM, and PP and surface alterations indicative of long-term deposition.
Assessment of type of microparticles
Measured: At enrolment
• Determination of plastic pollution exposure in patients with cirrhosis by detailed history of diet, oral and parenteral medication, interventions including prior biopsy and endoscopy
Assessment of gastric and duodenal mucosa for micronanoplastics during elective endoscopy.
Measured: At the time of elective endoscopy
Assessment of micronanoplastics in peripheral blood
Dried blood spots assessment of micronanoplastics
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 May 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Vellore Institute of Technology University
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Madhumita Premkumar, Principal investigator, PGIMER Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280390
- Sponsor's protocol ID
- PGI/IEC/2025/EIC000779
- Status last verified
- May 2026
- First submitted
- 1 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India
- ClinicalTrials.gov ID
- NCT07280390
- Acronym / sponsor ID
- PGI/IEC/2025/EIC000779
- Conditions
- Cirrhosis, Microplastics, Portal Hypertension Related to Cirrhosis, Nanoplastics, Pollution, Cirrhosis and Chronic Liver Disease
- Keywords
- Microplastics, Nanoplastics, Plastic pollution, Cirrhosis, Portal hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Vellore Institute of Technology University
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 12 Dec 2025 (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.
Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension.
Globally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health.
Polystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity.
The study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.
Detailed description
First, because the methodology requires chemical digestion, it is unclear where in the liver MPs are deposited. For instance, it is indeterminate if MPs are deposited intracellularly, in Kupffer cells, endothelium or hepatocytes/cholangiocytes. In the present study histopathological assessments of the liver tissue will be performed to determine the presence of the MPs.
- Furthermore, the study will assess various polymer types of MP in cirrhotic liver tissue including commonly observed plastic polymers PS (polystyrene), PE (polyethylene), PP (polypropylene), PVC (polyvinyl chloride), PET (polyethylene terephthalate), PC (polycarbonate), and PMMA (polymethyl methacrylate).
- Therefore, potential cellular sites of deposition in the liver will be assessed. If the MPs were in the systemic circulation, without any liver parenchymal residues, such particles should also be identified in spleen and kidney samples.
- histopathology and electron microscopy of the liver tissue which should clarify the specific accumulation sites.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cirrhosis | – | Diagnostic Test: Assessment of microplastics in tissueCirrhosis and Portal Hypertension who are getting elective surgery or liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis Healthy liver control tissue will be taken from autopsy patients with consent
Key inclusion criteria (3 listed)
- Age range of 18-70 years
- Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.
- Undergoing elective surgery or liver transplantation
Key exclusion criteria (4 listed)
- • Hepatocellular carcinoma
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 |
|---|---|---|
| Assessment of microplastics in tissueAfter meeting inclusion and exclusion criteria, 30 patients with cirrhosis will be included in this study with written informed consent from patient (surgical cases) or scheduled liver biopsy. Diagnosis of chronic liver disease will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy as recorded in the patient file, imaging studies (ultrasonography and doppler of splenoportal venous axis). Underlying etiology of liver disease will be recorded. Complications of cirrhosis like hepatorenal syndrome (HRS), spontaneous bacterial peritonitis (SBP), upper gastrointestinal bleed, hepatic encephalopathy, acute kidney injury will be recorded from the patient's casefile. Tissue Sample Processing Standard laboratory solvents (i.e., acetonitrile, methanol, and water (LiChrosolv and SupraSolv grade) will be procured. The contact of laboratory surfaces and equipment will be minimized to reduce the risk of background contamination by plastics. | Diagnostic test | Patients with Cirrhosis |
Primary outcome
The primary outcome is to assess MPs in human liver tissue, analysing their morphology, size, and composition (4-30 µm) in tissue samples from the liver inpatients with cirrhosis as compared with controls without cirrhosis
Time frame: At time of enrolment
MPs in liver cirrhosis
3 secondary outcomes
• Identification of Various polymer types, including PS, PVC, PET, PMMA, POM, and PP and surface alterations indicative of long-term deposition.
Time frame: At enrolment
• Determination of plastic pollution exposure in patients with cirrhosis by detailed history of diet, oral and parenteral medication, interventions including prior biopsy and endoscopy
Time frame: At the time of elective endoscopy
Assessment of micronanoplastics in peripheral blood
Time frame: At enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Madhumita Premkumar principal investigator
PGIMER Chandigarh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Microplastics, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar, MD DM (01722754777, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to assess MPs in human liver tissue, analysing their morphology, size, and composition (4-30 µm) in tissue samples from the liver inpatients with cirrhosis as compared with controls without cirrhosis (time frame: At time of enrolment). 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 15 May 2026.