Quality of Life and Nutritional Improvements in Cirrhotic Patients

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension

In brief

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).

Key facts

Study ID

NCT01842113

Run by

Tampa General Hospital

People needed

4

Starts

2013-04-01

Last updated by the study team

2013-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tampa General Medical Group — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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