The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

Status unconfirmed · Phase 2

Conditions studied: Hepatic Encephalopathy, Hepatitis C, Liver Cirrhosis

In brief

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.

Key facts

Study ID
NCT00281502
Run by
Weill Medical College of Cornell University
People needed
50
Starts
2005-12-01
Expected to finish
2012-12-01
Last updated by the study team
2010-11-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.