The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy
Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The study will be conducted in two phases. Phase A will evaluate the contribution of
bacterial overgrowth and colonic inertia to development of Hepatic Encephalopathy (HE)in 50
ambulatory subjects with HE and hepatitis C cirrhosis. This phase will include a Screening
and Evaluation Visit.
Phase B will evaluate the effect of rifaximin on bacterial outgrowth and severity of HE in 20
of the subjects enrolled in Phase A who have a somewhat greater degree of encephalopathy.
The purpose of this study is to evaluate the following:
1. the relationship between bacterial overgrowth and the presence and severity of HE in
patients with hepatitis C cirrhosis;
2. the effectiveness and tolerability of rifaximin relative to placebo in treatment of HE
associated with hepatitis C cirrhosis;
3. the relationship between bacterial overgrowth and the presence and severity of HE before
and after rifaximin treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.