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

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ClinicalTrials.gov 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
Sponsor:
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.

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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


Group/Cohort
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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02427906


Contacts
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Contact: Zhu Wang, PhD 18981745741 1988wangzhu@gmail.com
Contact: Mingshan Jiang, MD 15680951783 jmsalice333@hotmail.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Zhu Wang, PhD    18981745741    1988wangzhu@gmail.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: Zhu Wang, PhD West China Hospital
Additional Information:

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Responsible Party: Wang Zhu, MD, Medical Doctor, West China Hospital
ClinicalTrials.gov 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:
cirrhosis
gut microbiota
transjugular portosystemic shunt
hepatic encephalopathy
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases