- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069133
Study of Rifaximin in Minimal Hepatic Encephalopathy
December 10, 2012 updated by: Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
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
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rifaximin
|
550mg BID open-label
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brain activation on fMRI
Time Frame: 2 months
|
2 months
|
Microbiome constituents
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brain edema and brain metabolite concentration
Time Frame: 2 months
|
2 months
|
Metabolome of urine and serum
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jasmohan S Bajaj, MD, MSc, McGuire VA Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Estimate)
December 11, 2012
Last Update Submitted That Met QC Criteria
December 10, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAJAJ010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Minimal Hepatic Encephalopathy
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Tel-Aviv Sourasky Medical CenterUnknown
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Ain Shams UniversityCompletedMinimal Hepatic Encephalopathy
-
Mansoura UniversityCompletedMinimal Hepatic EncephalopathyEgypt
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Fondazione Policlinico Universitario Agostino Gemelli...CompletedMinimal Hepatic EncephalopathyItaly
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterInstituto Grifols, S.A.; McGuire Research InstituteCompletedHepatic Encephalopathy | Cirrhosis | Minimal Hepatic Encephalopathy | Covert Hepatic EncephalopathyUnited States
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Postgraduate Institute of Medical Education and...CompletedHepatic Encephalopathy | Minimal Hepatic EncephalopathyIndia
-
Virginia Commonwealth UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedMinimal Hepatic EncephalopathyUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedHepatic Cirrhosis | Minimal Hepatic EncephalopathyMexico
-
Medical College of WisconsinNational Center for Research Resources (NCRR)CompletedCirrhosis | Minimal Hepatic EncephalopathyUnited States
-
Imperial College LondonCompletedHepatic Encephalopathy | Cirrhosis | Minimal Hepatic EncephalopathyUnited Kingdom
Clinical Trials on Rifaximin
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Bausch Health Americas, Inc.CompletedIrritable Bowel Syndrome With DiarrheaUnited States, United Kingdom, Germany
-
Bausch Health Americas, Inc.CompletedSickle Cell DiseaseUnited States, Canada, Kenya
-
Bausch Health Americas, Inc.CompletedLiver CirrhosisUnited States, Russian Federation
-
Bausch Health Americas, Inc.CompletedOvert Hepatic EncephalopathyUnited States
-
Alfasigma S.p.A.TerminatedDiverticulitisFrance, Germany, Italy, Netherlands, Spain, United Kingdom
-
SandozTerminatedTravelers' DiarrheaMexico
-
Sun Yat-sen UniversityRecruitingHepatic Encephalopathy | Hepatitis B | HBV | Effect of Drug | Liver Failure, Acute on Chronic | RifaximinChina
-
National University Hospital, SingaporeNational University, SingaporeCompletedIrritable Bowel Syndrome With DiarrheaSingapore
-
Shanghai Changzheng HospitalUnknown
-
Bausch Health Americas, Inc.Active, not recruitingHepatic EncephalopathyUnited States, Australia, Canada, Puerto Rico