Overview

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