Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT02427906
Status:
UNKNOWN
Last Update Posted:
2015-10-27
First Post:
2015-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum，stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fecal microbiota', 'timeFrame': 'baseline and 6 month'}], 'secondaryOutcomes': [{'measure': 'Incidence of hepatic encephalopathy', 'timeFrame': '6 month'}, {'measure': 'Changes of blood inflammatory parameter including IL-2（interleukin 2）,IL-6,IL-10,IL-8，TNF-α', 'timeFrame': 'baseline and 6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cirrhosis', 'gut microbiota', 'transjugular portosystemic shunt', 'hepatic encephalopathy'], 'conditions': ['Cirrhosis', 'Acquired Portal-systemic Shunt Due to Cirrhosis', 'Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTIPS 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhotic patients who received TIPS;\n* Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)\n\nExclusion Criteria:\n\n* Uncontrolled infection or sepsis;\n* Hepatobiliary or pancreatic malignancy or biliary obstruction;\n* Vital organ dysfunction;\n* Administration of antibiotics (after TIPS and 2 weeks before TIPS);\n* Cachexia;\n* Pregnant or breeding women'}, 'identificationModule': {'nctId': 'NCT02427906', 'briefTitle': 'Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota and Associated Inflammatory Factors in Cirrhotic Patients', 'orgStudyIdInfo': {'id': '2014-151'}, 'secondaryIdInfos': [{'id': 'WCH-2014-151', 'type': 'OTHER', 'domain': 'West China Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'TIPS group', 'description': 'patients who have transjugular intrahepatic portosystemic shunt'}, {'label': 'Non-TIPS group', 'description': 'patients who have endoscopic variceal ligation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhu Wang, PhD', 'role': 'CONTACT', 'email': '1988wangzhu@gmail.com', 'phone': '18981745741'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Zhu Wang, PhD', 'role': 'CONTACT', 'email': '1988wangzhu@gmail.com', 'phone': '18981745741'}, {'name': 'Mingshan Jiang, MD', 'role': 'CONTACT', 'email': 'jmsalice333@hotmail.com', 'phone': '15680951783'}], 'overallOfficials': [{'name': 'Zhu Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Wang Zhu, MD', 'investigatorAffiliation': 'West China Hospital'}}}}