Quality of Life and Nutritional Improvements in Cirrhotic Patients

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

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).

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Hepatic Encephalopathy; Portal Hypertension
• Intervention / Treatment: Drug: Lactulose; Drug: Rifaximin Placebo; Drug: Rifaximin; Drug: Lactulose Placebo

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lactulose and Rifaximin Placebo; Standard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day.	Drug: Lactulose; Lactulose 30ml by mouth three times a day; Other Names: Enulose; Generlac; Cholac; Constulose; Kristalose; Laxilose; Portalac; Hepatalac; Constilac; Drug: Rifaximin Placebo; Rifaximin Placebo twice a day; Other Names: Sugar Pill
ACTIVE_COMPARATOR: Rifaximin and Lactulose Placebo; Rifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day.	Drug: Rifaximin; Rifaximin 550mg by mouth twice a day; Other Names: Xifaxan; Drug: Lactulose Placebo; Lactulose Placebo 30ml three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of Change in Quality of Life Assessment Between the Two Groups	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).	Participants will be followed for 180 days
Nutritional Improvement Between the Two Groups	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.	Participants will be followed for 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers of improvement in general health	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.	Participants will be followed for 180 days

Collaborators and Investigators

• Sponsor: Tampa General Hospital
• Investigators: Principal Investigator: Guy Neff, MD, MBA, Tampa General Medical Group

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): May 1, 2014

Study Registration Dates

• First Submitted: April 11, 2013
• First Submitted That Met QC Criteria: April 24, 2013
• First Posted (ESTIMATE): April 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Fibrosis; Brain Diseases, Metabolic; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Hypertension, Portal; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: Rifaximin and Nutrition