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

• Conditions: Cirrhosis; Hepatic Encephalopathy; Acquired Portal-systemic Shunt Due to Cirrhosis

• Registration Number: NCT02427906
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-27
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in fecal microbiota	baseline and 6 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China