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Completed

NCT Number: NCT01069133

Study of Rifaximin in Minimal Hepatic Encephalopathy

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

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Key information

Conditions

Minimal Hepatic Encephalopathy Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

550mg BID open-label

Other names: xifaxan

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

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2010
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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