Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tampa General Hospital
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Quality of Life and Nutritional Improvements in Cirrhotic Patients
