Study of Rifaximin in Minimal Hepatic Encephalopathy

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069133

Enrollment

Registered

2010-02-17

Start date

2010-02-28

Completion date

2012-12-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Hepatic Encephalopathy

Keywords

minimal hepatic encephalopathy, cirrhosis, complications

Brief summary

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

Interventions

DRUGRifaximin

550mg BID open-label

DRUGrifaximin

550mg PO BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
brain activation on fMRI	2 months
Microbiome constituents	8 weeks

Secondary

Measure	Time frame
brain edema and brain metabolite concentration	2 months
Metabolome of urine and serum	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026