Study of Rifaximin in Minimal Hepatic Encephalopathy

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Minimal Hepatic Encephalopathy

Treatments: Drug: rifaximin; Drug: Rifaximin

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01069133

BAJAJ010

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Rifaximin

Experimental group

Treatment:

Drug: Rifaximin