COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02427906
Recruitment Status : Unknown
Verified October 2015 by Wang Zhu, MD, West China Hospital.
Recruitment status was:  Recruiting
First Posted : April 28, 2015
Last Update Posted : October 27, 2015
Information provided by (Responsible Party):
Wang Zhu, MD, 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.

Condition or disease
Cirrhosis Acquired Portal-systemic Shunt Due to Cirrhosis Hepatic Encephalopathy

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients
Study Start Date : August 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

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

Primary Outcome Measures :
  1. Changes in fecal microbiota [ Time Frame: baseline and 6 month ]

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

Biospecimen Retention:   Samples With DNA
whole blood, serum,stool

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02427906

Layout table for location contacts
Contact: Zhu Wang, PhD 18981745741
Contact: Mingshan Jiang, MD 15680951783

Layout table for location information
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Zhu Wang, PhD    18981745741   
Sponsors and Collaborators
West China Hospital
Layout table for investigator information
Study Chair: Zhu Wang, PhD West China Hospital
Additional Information:

Layout table for additonal information
Responsible Party: Wang Zhu, MD, Medical Doctor, West China Hospital Identifier: NCT02427906    
Other Study ID Numbers: 2014-151
WCH-2014-151 ( Other Identifier: West China Hospital )
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Keywords provided by Wang Zhu, MD, West China Hospital:
gut microbiota
transjugular portosystemic shunt
hepatic encephalopathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases