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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02427906
• Other study ID #: 2014-151
• Secondary ID: WCH-2014-151
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: October 26, 2015
• Start date: August 2014
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: West China Hospital
• Contact: Zhu Wang, PhD
• Phone: 18981745741
• Email: 1988wangzhu[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Portal-systemic Shunt Due to Cirrhosis
• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fecal microbiota		baseline and 6 month	No
Secondary	Incidence of hepatic encephalopathy		6 month	No
Secondary	Changes of blood inflammatory parameter including IL-2(interleukin 2),IL-6,IL-10,IL-8,TNF-a		baseline and 6 month	No