- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280390
Microplastics, Cirrhosis and Portal Hypertension
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Madhumita Premkumar, MD DM
- Phone Number: 01722754777
- Email: drmadhumitap@gmail.com
Study Locations
-
-
Chandigarh
-
Chandigarh, Chandigarh, India, 160012
- Recruiting
- Dr. Madhumita Premkumar
-
Contact:
- Dr. Madhumita Premkumar, MD
- Phone Number: +919540951061
- Email: drmadhumitap@gmail.com
-
Chandigarh, Chandigarh, India, 160012
- Recruiting
- PGIMER Chandigarh
-
Contact:
- Prerna Premkumar
- Phone Number: 01722754777
- Email: drmadhumitap@gmail.com
-
Contact:
- Email: drmadhumitap@gmail.com
-
Principal Investigator:
- Dr. Madhumita Premkumar, MD DM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age range of 18-70 years
- Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.
- Undergoing elective surgery or liver transplantation
Exclusion Criteria:
• Hepatocellular carcinoma
- Pregnancy or lactation
- Patients with HIV or retroviral therapy
- Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Cirrhosis
Cirrhosis and Portal Hypertension who are getting elective surgery or liver transplantation
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At time of enrolment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• 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
|
Assessment of type of microparticles
|
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 gastric and duodenal mucosa for micronanoplastics during elective endoscopy.
|
At the time of elective endoscopy
|
|
Assessment of micronanoplastics in peripheral blood
Time Frame: At enrolment
|
Dried blood spots assessment of micronanoplastics
|
At enrolment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of microplastics with degree of liver fibrosis and inflammation
Time Frame: At enrolment
|
Comparison of presence of microplastics with histopathological inflammation and presence of fibrosis grade.
|
At enrolment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Madhumita Premkumar, PGIMER Chandigarh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Digestive System Diseases
- Liver Diseases
- Pathological Conditions, Signs and Symptoms
- Fibrosis
- Hypertension, Portal
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Immunologic Techniques
- Immunologic Tests
- Histocompatibility Testing
Other Study ID Numbers
- PGI/IEC/2025/EIC000779
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
University Health Network, TorontoUnknown
-
Northwestern UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsActive, not recruitingCirrhosis | Autoimmune Hepatitis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis AlcoholicUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingPrimary Biliary CirrhosisChina
-
Institute of Liver and Biliary Sciences, IndiaIndian Council of Medical ResearchNot yet recruiting
-
RenJi HospitalNot yet recruiting
-
Nanfang Hospital, Southern Medical UniversityRecruiting
-
Institute of Liver and Biliary Sciences, IndiaRecruiting
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
Clinical Trials on Assessment of microplastics in tissue
-
Universiteit AntwerpenKU LeuvenRecruiting
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Jonsson Comprehensive Cancer CenterNitional institute of Health -National Center for Advancing Translational...RecruitingGlioblastoma Multiforme | Epidermal Growth Factor Receptor | Glycolytic IndexUnited States
-
Isfahan University of Medical SciencesCompletedTotal Knee Replacement | Total Knee Arthroplasty(TKA)Iran, Islamic Republic of
-
Cairo UniversityUnknown
-
Eliz ArterCyprus Science UniversityCompleted
-
University Hospital, RouenRecruitingNeurocognitive Disorders | Alzheimer's DiseaseFrance
-
University of AarhusUniversity of Southern Denmark; UiT The Arctic University of NorwayCompletedPerianal Fistula | Adipose Tissue | Tissue Transplantation
-
Fundación Investigación Sanitaria en LeónCompletedEndometrial Neoplasm MalignantSpain