The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
Status:
Terminated
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
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.