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Clinical Trials/NCT02427906
NCT02427906
Unknown
Not Applicable

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

West China Hospital1 site in 1 country50 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cirrhosis
Sponsor
West China Hospital
Enrollment
50
Locations
1
Primary Endpoint
Changes in fecal microbiota
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
April 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wang Zhu, MD

Medical Doctor

West China Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in fecal microbiota

Time Frame: baseline and 6 month

Secondary Outcomes

  • 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)

Study Sites (1)

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