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Trial record 1 of 1 for:    NCT01069133
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Study of Rifaximin in Minimal Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069133
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : December 11, 2012
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief Summary:
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.

Condition or disease Intervention/treatment Phase
Minimal Hepatic Encephalopathy Drug: Rifaximin Drug: rifaximin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin Drug: Rifaximin
550mg BID open-label
Other Name: xifaxan

Drug: rifaximin
550mg PO BID
Other Name: xifaxan

Primary Outcome Measures :
  1. brain activation on fMRI [ Time Frame: 2 months ]
  2. Microbiome constituents [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. brain edema and brain metabolite concentration [ Time Frame: 2 months ]
  2. Metabolome of urine and serum [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-65 years
  • 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:

  • Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.
  • Prior episodes of overt HE
  • MMSE <25
  • TIPS placement
  • Unable to give informed consent.
  • Contra-indications to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01069133

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United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Bausch Health Americas, Inc.
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Principal Investigator: Jasmohan S Bajaj, MD, MSc McGuire VA Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jasmohan Bajaj, Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier: NCT01069133    
Other Study ID Numbers: BAJAJ010
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012
Keywords provided by Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center:
minimal hepatic encephalopathy
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents