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
1 other identifier
interventional
20
1 country
1
Brief Summary
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 11, 2012
December 1, 2012
2.2 years
February 16, 2010
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
brain activation on fMRI
2 months
Microbiome constituents
8 weeks
Secondary Outcomes (2)
brain edema and brain metabolite concentration
2 months
Metabolome of urine and serum
8 weeks
Study Arms (1)
Rifaximin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Related Publications (1)
Bajaj JS, Heuman DM, Sanyal AJ, Hylemon PB, Sterling RK, Stravitz RT, Fuchs M, Ridlon JM, Daita K, Monteith P, Noble NA, White MB, Fisher A, Sikaroodi M, Rangwala H, Gillevet PM. Modulation of the metabiome by rifaximin in patients with cirrhosis and minimal hepatic encephalopathy. PLoS One. 2013;8(4):e60042. doi: 10.1371/journal.pone.0060042. Epub 2013 Apr 2.
PMID: 23565181DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jasmohan S Bajaj, MD, MSc
McGuire VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2012
Study Completion
December 1, 2012
Last Updated
December 11, 2012
Record last verified: 2012-12