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Microbiome Translocation in Different Circulatory Compartments in Decompensated Cirrhosis

Microbiome Translocation in Different Circulatory Compartments in Decompensated Cirrhosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04195724
Enrollment
15
Registered
2019-12-12
Start date
2019-11-28
Completion date
2021-12-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver

Keywords

gut microbial translocation, metagenomic next-generation sequencing, transjugular intrahepatic portosystemic shunt

Brief summary

Acquired dysfunctional immunity in cirrhosis predisposes patients to frequent bacterial infections contributing to disease progression and may lead to the development of acute-on-chronic liver failure (ACLF). Spontaneous bacterial peritonitis (SBP) is one of the most frequent infections in cirrhosis and therefore a trigger for ACLF. ACLF is characterized by systemic inflammation even in the absence of confirmed infection and associated with poor outcome. The source of ascites infection, especially in case of culture-positive SBP and bacterascites, is suspected to be bacterial translocation from gut. 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.

Interventions

mNGS for pathogen detection and metabonomics (ascites, fecal,venous blood from superior mesenteric vein, hepatic vein and peripheral vein, respectively)

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age\>18 years old; 2. Patients with decompensated liver cirrhosis; 3. Patients receiving TIPS for either variceal bleeding or refractory ascites.

Exclusion criteria

1. Hepatic tumor or extrahepatic related cancer; 2. Not provide written consent.

Design outcomes

Primary

MeasureTime frameDescription
The circulating microbiome in ascites,fecal and in blood of different circulatory compartments (superior mesenteric vein, peripheral vein and hepatic vein, respectively).28 daysmNGS and metabonomics are performed in ascites,fecal and in blood of different circulatory compartments (superior mesenteric vein, peripheral vein and hepatic vein, respectively).

Secondary

MeasureTime frameDescription
The improvement of gut microbiome translocation 6 months after the operation of TIPS.6 months after dischargeThe improvement of gut microbiome translocation 6 months is evaluated after the operation of TIPS.
The occurrence of decompensated events (infection, ascites, hepatic encephalopathy, gastrointestinal bleeding) 1 year after the operation of TIPS.1 years after dischargeThe occurrence of decompensated events are recorded during follow-up.

Countries

China

Contacts

Primary ContactJinjun Chen
chjj@smu.edu.cn8618588531001
Backup ContactBeiling Li
lbling123@163.com8613570541527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026