CirrhosisNCT02427906
Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients
An observational study of Cirrhosis and Acquired Portal-systemic Shunt Due to Cirrhosis, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Acquired Portal-systemic Shunt Due to Cirrhosis, Hepatic Encephalopathy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Apr 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital
Who may be able to join
- Cirrhotic patients who received TIPS;
- Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Zhu Wang, PhD, 18981745741, 1988wangzhu@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- cirrhosis, gut microbiota, transjugular portosystemic shunt, hepatic encephalopathy
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TIPS group | patients who have transjugular intrahepatic portosystemic shunt | |
| Non-TIPS group | patients who have endoscopic variceal ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fecal microbiota
Measured: baseline and 6 month
Secondary outcomes (2)
Incidence of hepatic encephalopathy
Measured: 6 month
Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α
Measured: baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zhu, MD, West China Hospital
- Investigators
- Zhu Wang, PhD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427906
- Sponsor's protocol ID
- 2014-151
- Other IDs
- WCH-2014-151
- Status last verified
- Oct 2015
- First submitted
- 6 Apr 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02427906
- Acronym / sponsor ID
- 2014-151
- Keywords
- cirrhosis, gut microbiota, transjugular portosystemic shunt, hepatic encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS group | – | –patients who have transjugular intrahepatic portosystemic shunt |
| Non-TIPS group | – | –patients who have endoscopic variceal ligation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital
Key inclusion criteria (2 listed)
- Cirrhotic patients who received TIPS;
- Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in fecal microbiota
Time frame: baseline and 6 month
2 secondary outcomes
Incidence of hepatic encephalopathy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Wang, PhD study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Acquired Portal-systemic Shunt Due to Cirrhosis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Wang, PhD (18981745741, 1988wangzhu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fecal microbiota (time frame: baseline and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.