Microbiome Translocation in Different Circulatory Compartments in Decompensated Cirrhosis
NCT ID: NCT04195724
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2019-11-28
2021-12-31
Brief Summary
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In decompensated cirrhosis, data on the gut microbial translocation in different circulatory compartments is limited. Moreover, the link between gut microbiome and systemic inflammation in liver disease has still not established.
The transjugular intrahepatic portosystemic shunt (TIPS) is applied to treat portal hypertension which frequently leads to intestinal bleeding, life-threatening esophageal bleeding and ascites. Under the procedure of TIPS, the vein blood samples in different compartments (superior mesenteric vein, portal vein and hepatic vein) from patients with decompensated liver cirrhosis are available. Metagenomic next-generation sequencing (mNGS) is a promise approach for the diagnosis of infectious disease because a comprehensive spectrum of potential causes (viral, bacterial, fungal, and parasitic) can be identified by a single assay. Previous study reported that mNGS of cerebrospinal fluid can be applied to diagnosis of meningitis and encephalitis. Comparing to traditional bacterial culture method, mNGS method is more sensitive and rapidly in pathogen detection. Therefore, the circulating microbiome in different compartment can be characterized by means of mNGS.
Here, the study aim to investigate the circulating microbiome from superior mesenteric vein (first venous outflow in gut-liver axis), hepatic vein (liver outflow), peripheral vein and ascites from patients with decompensated liver cirrhosis receiving TIPS. Before TIPS, fecal sample and unary sample are collected. And mNGS method is performed to identify the pathogen in ascites,fecal and blood samples in a single center. Ultimately, the study aim to build up the link between gut microbiome translocation and liver disease.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with decompensated ascites and receiving TIPS
Patients with decompensated ascites and receiving TIPS will be enrolled. In this study, diagnostic paracentesis will be performed to get the ascites sample before the patients receiving TIPS. Next, the blood sample from superior mesenteric vein and hepatic vein will be collected under the procedure of TIPS.
mNGS for pathogen detection
mNGS for pathogen detection and metabonomics (ascites, fecal,venous blood from superior mesenteric vein, hepatic vein and peripheral vein, respectively)
Interventions
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mNGS for pathogen detection
mNGS for pathogen detection and metabonomics (ascites, fecal,venous blood from superior mesenteric vein, hepatic vein and peripheral vein, respectively)
Eligibility Criteria
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Inclusion Criteria
2. Patients with decompensated liver cirrhosis;
3. Patients receiving TIPS for either variceal bleeding or refractory ascites.
Exclusion Criteria
2. Not provide written consent.
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Jinjun Chen
Hepatology Unit, Department of Infectious Diseases
Principal Investigators
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Jinjun Chen
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jinjun Chen
Role: primary
Other Identifiers
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12
Identifier Type: -
Identifier Source: org_study_id