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Study of Rifaximin in Minimal Hepatic Encephalopathy

Primary Purpose

Minimal Hepatic Encephalopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
rifaximin
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minimal Hepatic Encephalopathy focused on measuring minimal hepatic encephalopathy, cirrhosis, complications

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rifaximin

Arm Description

Outcomes

Primary Outcome Measures

brain activation on fMRI
Microbiome constituents

Secondary Outcome Measures

brain edema and brain metabolite concentration
Metabolome of urine and serum

Full Information

First Posted
February 16, 2010
Last Updated
December 10, 2012
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01069133
Brief Title
Study of Rifaximin in Minimal Hepatic Encephalopathy
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Hepatic Encephalopathy
Keywords
minimal hepatic encephalopathy, cirrhosis, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
xifaxan
Intervention Description
550mg BID open-label
Intervention Type
Drug
Intervention Name(s)
rifaximin
Other Intervention Name(s)
xifaxan
Intervention Description
550mg PO BID
Primary Outcome Measure Information:
Title
brain activation on fMRI
Time Frame
2 months
Title
Microbiome constituents
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
brain edema and brain metabolite concentration
Time Frame
2 months
Title
Metabolome of urine and serum
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MD, MSc
Organizational Affiliation
McGuire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23565181
Citation
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.
Results Reference
derived

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Study of Rifaximin in Minimal Hepatic Encephalopathy

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