Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT01069133
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2010-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Rifaximin in Minimal Hepatic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brain activation on fMRI', 'timeFrame': '2 months'}, {'measure': 'Microbiome constituents', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'brain edema and brain metabolite concentration', 'timeFrame': '2 months'}, {'measure': 'Metabolome of urine and serum', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['minimal hepatic encephalopathy', 'cirrhosis', 'complications'], 'conditions': ['Minimal Hepatic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '23565181', 'type': 'DERIVED', 'citation': 'Bajaj JS, Heuman DM, Sanyal AJ, Hylemon PB, Sterling RK, Stravitz RT, Fuchs M, Ridlon JM, Daita K, Monteith P, Noble NA, White MB, Fisher A, Sikaroodi M, Rangwala H, Gillevet PM. Modulation of the metabiome by rifaximin in patients with cirrhosis and minimal hepatic encephalopathy. PLoS One. 2013;8(4):e60042. doi: 10.1371/journal.pone.0060042. Epub 2013 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* cirrhosis diagnosed by clinical or biopsy grounds\n* Minimal hepatic encephalopathy defined by impaired performance on at least 2 of the following: number connection tests A/B, digit symbol and block design tests (NCT-A, NCT-B, DST and BDT) compared to age and education-matched controls.\n* No contraindications to MRI\n* TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks\n\nExclusion Criteria:\n\n* Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.\n* Prior episodes of overt HE\n* MMSE \\<25\n* TIPS placement\n* Unable to give informed consent.\n* Contra-indications to MRI'}, 'identificationModule': {'nctId': 'NCT01069133', 'briefTitle': 'Study of Rifaximin in Minimal Hepatic Encephalopathy', 'organization': {'class': 'FED', 'fullName': 'Hunter Holmes Mcguire Veteran Affairs Medical Center'}, 'officialTitle': 'Effect of Rifaximin Therapy on Brain Activation in Patients With Minimal Hepatic Encephalopathy Using Functional MR, MR Spectroscopy,Diffusion Tensor Imaging Microbiome and Metabolome: a Prospective Trial', 'orgStudyIdInfo': {'id': 'BAJAJ010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifaximin', 'interventionNames': ['Drug: Rifaximin']}], 'interventions': [{'name': 'Rifaximin', 'type': 'DRUG', 'otherNames': ['xifaxan'], 'description': '550mg BID open-label', 'armGroupLabels': ['Rifaximin']}, {'name': 'rifaximin', 'type': 'DRUG', 'otherNames': ['xifaxan'], 'description': '550mg PO BID', 'armGroupLabels': ['Rifaximin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Jasmohan S Bajaj, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGuire VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter Holmes Mcguire Veteran Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Jasmohan Bajaj', 'investigatorAffiliation': 'Hunter Holmes Mcguire Veteran Affairs Medical Center'}}}}