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

October 26, 2015 updated by: Wang Zhu, MD, West China Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
TIPS group
patients who have transjugular intrahepatic portosystemic shunt
Non-TIPS group
patients who have endoscopic variceal ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in fecal microbiota
Time Frame: baseline and 6 month
baseline and 6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Chair: Zhu Wang, PhD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-151
  • WCH-2014-151 (Other Identifier: West China Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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