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Study of Rifaximin in Minimal Hepatic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069133
First Posted: February 17, 2010
Last Update Posted: December 11, 2012
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.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
February 16, 2010
February 17, 2010
December 11, 2012
February 2010
May 2012   (Final data collection date for primary outcome measure)
  • brain activation on fMRI [ Time Frame: 2 months ]
  • Microbiome constituents [ Time Frame: 8 weeks ]
brain activation on fMRI [ Time Frame: 2 months ]
Complete list of historical versions of study NCT01069133 on ClinicalTrials.gov Archive Site
  • brain edema and brain metabolite concentration [ Time Frame: 2 months ]
  • Metabolome of urine and serum [ Time Frame: 8 weeks ]
brain edema and brain metabolite concentration [ Time Frame: 2 months ]
Not Provided
Not Provided
 
Study of Rifaximin in Minimal Hepatic Encephalopathy
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
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Minimal Hepatic Encephalopathy
  • Drug: Rifaximin
    550mg BID open-label
    Other Name: xifaxan
  • Drug: rifaximin
    550mg PO BID
    Other Name: xifaxan
Experimental: Rifaximin
Interventions:
  • Drug: Rifaximin
  • Drug: rifaximin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01069133
BAJAJ010
No
Not Provided
Not Provided
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Jasmohan S Bajaj, MD, MSc McGuire VA Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP