Study of Rifaximin in Minimal Hepatic Encephalopathy

Minimal Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069133
• Other study ID #: BAJAJ010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 16, 2010
• Last updated: December 10, 2012
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Minimal Hepatic Encephalopathy

Intervention

Drug:
• Rifaximin
550mg BID open-label
• rifaximin
550mg PO BID

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain activation on fMRI		2 months	No
Primary	Microbiome constituents		8 weeks	No
Secondary	brain edema and brain metabolite concentration		2 months	No
Secondary	Metabolome of urine and serum		8 weeks	No