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

NCT ID: NCT02427906

Last Updated: 2015-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis Acquired Portal-systemic Shunt Due to Cirrhosis Hepatic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TIPS group

patients who have transjugular intrahepatic portosystemic shunt

No interventions assigned to this group

Non-TIPS group

patients who have endoscopic variceal ligation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wang Zhu, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhu Wang, PhD

Role: STUDY_CHAIR

West China Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhu Wang, PhD

Role: CONTACT

18981745741

Mingshan Jiang, MD

Role: CONTACT

15680951783

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhu Wang, PhD

Role: primary

18981745741

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WCH-2014-151

Identifier Type: OTHER

Identifier Source: secondary_id

2014-151

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.