Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients

Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02427906

Enrollment

Registered

2015-04-28

Start date

2014-08-31

Completion date

2016-04-30

Last updated

2015-10-27

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

Conditions

Acquired Portal-systemic Shunt Due to Cirrhosis, Cirrhosis, Hepatic Encephalopathy

Keywords

cirrhosis, gut microbiota, transjugular portosystemic shunt, hepatic encephalopathy

Brief summary

The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

Detailed description

Cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (HE) and infections. Dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation. TIPS can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. Hence we summarize that TIPS may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Cirrhotic patients who received TIPS; * Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)

Exclusion criteria

* Uncontrolled infection or sepsis; * Hepatobiliary or pancreatic malignancy or biliary obstruction; * Vital organ dysfunction; * Administration of antibiotics (after TIPS and 2 weeks before TIPS); * Cachexia; * Pregnant or breeding women

Design outcomes

Primary

Measure	Time frame
Changes in fecal microbiota	baseline and 6 month

Secondary

Measure	Time frame
Incidence of hepatic encephalopathy	6 month
Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α	baseline and 6 month

Countries

China

Contacts

Primary ContactZhu Wang, PhD

1988wangzhu@gmail.com18981745741

Backup ContactMingshan Jiang, MD

jmsalice333@hotmail.com15680951783

Outcome results