Trial | NCT01842113  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    lactulose rifaximin ...

  • Study Participants

    4
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).
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.
Study Started
Apr 30
2013
Primary Completion
May 31
2014
Anticipated
Last Update
Sep 23
2013
Estimate

Drug Rifaximin

Rifaximin 550mg by mouth twice a day

  • Other names: Xifaxan

Drug Lactulose

Lactulose 30ml by mouth three times a day

  • Other names: Enulose, Generlac, Cholac, Constulose, Kristalose, Laxilose, Portalac, Hepatalac, Constilac

Drug Lactulose Placebo

Lactulose Placebo 30ml three times a day

Drug Rifaximin Placebo

Rifaximin Placebo twice a day

  • Other names: Sugar Pill

Lactulose and Rifaximin Placebo Active Comparator

Standard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day.

Rifaximin and Lactulose Placebo Active Comparator

Rifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day.

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
No Results Posted