Quality of Life and Nutritional Improvements in Cirrhotic Patients

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampa General Hospital
• Treatments: Lactulose; Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Male and female gender of Age 18 years or older

• Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis

• Model for End Stage Liver Disease (MELD) score < 20

• Willingness to provide written informed consent, and participate in all study requirements

• Sodium greater than 130 meq/L

• Conn Score < 2

Exclusion Criteria:

• Active alcohol consumption

• Serum total bilirubin level > 5 mg/dl

• History of hepatocellular carcinoma (HCC) and malignancies other than basal cell carcinoma of the skin

• Pregnant or breastfeeding women

• Subject has renal insufficiency requiring routine dialysis

• Poorly controlled diabetes as defined by HgA1C > 10

• Narcotic/psychotropic usage other than a stable dose of antidepressant and/or methadone. Neurontin (gabapentin) and Lyrica (pregabalin) are permitted if the subject has been on a stable dose for at least 2 months prior to the screening visit and no change of dosing is expected throughout the length of the trial

• Any of the following diagnoses:

• HIV

• Evidence of severe concomitant illness or any condition that makes them unsuitable for the study in the opinion of the investigator(s)

• Subject has received an investigational drug within 30 days prior to enrollment