Quality of Life and Nutritional Improvements in Cirrhotic Patients

Phase 4

Terminated

• Conditions: Portal Hypertension; Liver Cirrhosis; Hepatic Encephalopathy
• Interventions: Drug: Rifaximin; Drug: Lactulose; Drug: Rifaximin Placebo; Drug: Lactulose Placebo

• Registration Number: NCT01842113
• Lead Sponsor: Tampa General Hospital

Brief 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).

Detailed Description

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-20
• Last Update Posted: 2013-09-23
• Primary Completion: 2014-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Outcomes of Change in Quality of Life Assessment Between the Two Groups	Participants will be followed for 180 days	Quality of Life will be determined by the Chronic Liver Disease Foundation Questionnaire (CLDQ), the Sleep Scale by Hays, R.D.\&Stewart, A.L. and the Multidimensional Assessment of Fatigue (MAF) Scale and measured based upon Subjective Global Assessment (SGA).
Nutritional Improvement Between the Two Groups	Participants will be followed for 180 days	These outcomes will be determined as Body Composition Analysis via the Quadscan 4000 BIA device manufactured by Bodystat;calories burned, steps taken and levels of physical activity to sleep efficiency will be measured via the Bodymedia CORE Fit actigraph device and various standard of care laboratories.

Secondary Outcome Measures

Name	Time	Method
Markers of improvement in general health	Participants will be followed for 180 days	These outcomes will be determined as Body Composition Analysis via the Quadscan 4000 BIA device manufactured by Bodystat;calories burned, steps taken and levels of physical activity to sleep efficiency will be measured via the Bodymedia CORE Fit actigraph device and various standard of care laboratories.

Trial Locations

Locations (1)

Tampa General Medical Group; 🇺🇸 Tampa, Florida, United States