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

S

Sichuan University

Status

Unknown

Conditions

Hepatic Encephalopathy
Cirrhosis
Acquired Portal-systemic Shunt Due to Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

NCT02427906
WCH-2014-151 (Other Identifier)
2014-151

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

50 participants in 2 patient groups

TIPS group
Description:
patients who have transjugular intrahepatic portosystemic shunt
Non-TIPS group
Description:
patients who have endoscopic variceal ligation

Trial contacts and locations

1

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Central trial contact

Mingshan Jiang, MD; Zhu Wang, PhD

Data sourced from clinicaltrials.gov

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