Hepatic Encephalopathy | The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
Hepatic Encephalopathy research study
What is the primary objective of this study?
This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test patients with cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to decreased bacterial overgrowth. Subjects' mental capacity will be assessed at each visit via interview, brief mental status, questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness, concentration, or understanding of evaluation, will be discontinued from the study. Female subjects of childbearing potential will be asked to comply with the use of contraception during the Phase B study period as well as throughout the time they remain on study drug.
Who is eligible to participate?
Inclusion Criteria: - Ambulatory patients with HCV cirrhosis will be screened for participation in the study - Ability to complete Number Connection Test - Creatinine <1.5mg/dL - Able to provide informed consent - Patients determined to possibly meet the West Haven criteria grade 0 or 1 for HE Exclusion Criteria: - Active interferon therapy - History of alcohol abuse within six months - Active gastrointestinal bleeding - Use of agents that alter intestinal motility, e.g., methadone, cholestyramine, Tricyclic antidepressants, etc. - Use of Neomycin or other antibiotics within the past 2 weeks - Pregnancy - Unable to provide informed consent
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:RifaximinParticipants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RifaximinParticipants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.
Start Date: September 2012
Completed Date: March 2016
Primary Outcome: Lactulose Hydrogen Breath Test
Secondary Outcome: Hepatic Encephalopathy
Study sponsors, principal investigator, and references
Principal Investigator: Samuel Sigal, M.D.
Lead Sponsor: New York University School of Medicine
Collaborator: Valeant Pharmaceuticals International, Inc.