Study of Rifaximin in Minimal Hepatic Encephalopathy

This study has been completed.
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier:
First received: February 16, 2010
Last updated: December 10, 2012
Last verified: December 2012
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.

Condition Intervention Phase
Minimal Hepatic Encephalopathy
Drug: Rifaximin
Drug: rifaximin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Primary Outcome Measures:
  • brain activation on fMRI [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Microbiome constituents [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • brain edema and brain metabolite concentration [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Metabolome of urine and serum [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin Drug: Rifaximin
550mg BID open-label
Other Name: xifaxan
Drug: rifaximin
550mg PO BID
Other Name: xifaxan


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01069133

United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Jasmohan S Bajaj, MD, MSc McGuire VA Medical Center
  More Information

No publications provided by Hunter Holmes Mcguire Veteran Affairs Medical Center

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jasmohan Bajaj, Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier: NCT01069133     History of Changes
Other Study ID Numbers: BAJAJ010
Study First Received: February 16, 2010
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
minimal hepatic encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015