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CompletedNCT01069133Updated Dec 11, 2012

Study of Rifaximin in Minimal Hepatic Encephalopathy

A Phase 1/2 interventional study of Rifaximin and rifaximin in Minimal Hepatic Encephalopathy, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-12-11.

Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Minimal Hepatic Encephalopathy

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Keywords

  • minimal hepatic encephalopathy
  • cirrhosis
  • complications
03

In context

Fibrosis

3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 2,137 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center is the lead sponsor of 31 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Rifaximin

    Drug: Rifaximin

Interventions

  • DrugRifaximin

    550mg BID open-label

    Also known as: xifaxan

  • Drugrifaximin

    550mg PO BID

    Also known as: xifaxan

06

What researchers measure

Primary outcomes

  1. brain activation on fMRI

    Time frame: 2 months

  2. Microbiome constituents

    Time frame: 8 weeks

Secondary outcomes

  1. brain edema and brain metabolite concentration

    Time frame: 2 months

  2. Metabolome of urine and serum

    Time frame: 8 weeks

07

Study locations

1 site
  • Hunter Holmes McGuire VA Medical Center
    Richmond, Virginia 23249, United States
08

References and documents

Publications

  • 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. PubMed 23565181 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01069133
Lead sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Bausch Health Americas, Inc.
Responsible party
Jasmohan Bajaj (Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center) — Principal investigator
First posted
Feb 17, 2010
Start date
Feb 2010
Primary completion
May 2012
Completion
Dec 2012
Last update
Dec 11, 2012

Study contacts

Jasmohan S Bajaj, MD, MSc
principal investigator · McGuire VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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