NCT01842113

Quality of Life and Nutritional Improvements in Cirrhotic Patients

Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Tampa General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic patients suffering from hepatic encephalopathy (HE).

Detailed description

Prevention of portal hypertension complications should be at the forefront. In doing so, the end result will be an improvement in the multitude of morbidity and mortality issues. The proposed prospective trial will compare patients with similar demographics and medical and clinical settings utilizing standard of care therapy. Study subjects will be randomly assigned into two treatment groups. Group one will receive Lactulose 30ml three times a day as SOC and Rifaximin Placebo 550mg twice a day with nutritional supervision and group two will receive Rifaximin 550mg twice per day as SOC and Lactulose placebo 30ml three times per day with nutritional supervision.

Conditions

• Liver Cirrhosis
• Hepatic Encephalopathy
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin 550mg by mouth twice a day
DRUG	Lactulose	Lactulose 30ml by mouth three times a day
DRUG	Lactulose Placebo	Lactulose Placebo 30ml three times a day
DRUG	Rifaximin Placebo	Rifaximin Placebo twice a day

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-05-01
• First posted: 2013-04-29
• Last updated: 2013-09-23

Locations

1 site across 1 country: United States