Study of Rifaximin in Minimal Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01069133
First received: February 16, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069133

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Salix Pharmaceuticals
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jasmohan Bajaj, Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov 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
cirrhosis
complications

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
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014