Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2010-02-28
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rifaximin
Rifaximin
550mg BID open-label
rifaximin
550mg PO BID
Interventions
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Rifaximin
550mg BID open-label
rifaximin
550mg PO BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cirrhosis diagnosed by clinical or biopsy grounds
* 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.
* No contraindications to MRI
* TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks
Exclusion Criteria
* Prior episodes of overt HE
* MMSE \<25
* TIPS placement
* Unable to give informed consent.
* Contra-indications to MRI
18 Years
65 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Hunter Holmes Mcguire Veteran Affairs Medical Center
FED
Responsible Party
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Jasmohan Bajaj
Associate Professor of Medicine
Principal Investigators
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Jasmohan S Bajaj, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McGuire VA Medical Center
Locations
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Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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BAJAJ010
Identifier Type: -
Identifier Source: org_study_id