Study of Rifaximin in Minimal Hepatic Encephalopathy

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

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