Study of Rifaximin in Minimal Hepatic Encephalopathy

Phase 1

Completed

• Conditions: Minimal Hepatic Encephalopathy
• Interventions: Drug: rifaximin

• Registration Number: NCT01069133
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2012-05
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rifaximin	rifaximin	-

Primary Outcome Measures

Name	Time	Method
brain activation on fMRI	2 months
Microbiome constituents	8 weeks

Secondary Outcome Measures

Name	Time	Method
brain edema and brain metabolite concentration	2 months
Metabolome of urine and serum	8 weeks

Trial Locations

Locations (1)

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States