Study of Rifaximin in Minimal Hepatic Encephalopathy

Phase 2CompletedNCT01069133

Hunter Holmes Mcguire Veteran Affairs Medical Center20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Minimal Hepatic Encephalopathy

Interventions

RifaximinDRUG

550mg BID open-label

rifaximinDRUG

550mg PO BID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

brain activation on fMRI

Time frame: 2 months

Microbiome constituents

Time frame: 8 weeks

Secondary Outcomes

brain edema and brain metabolite concentration

Time frame: 2 months

Metabolome of urine and serum

Time frame: 8 weeks

Data from ClinicalTrials.gov

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