Quality of Life and Nutritional Improvements in Cirrhotic Patients

NCT01842113 | Terminated Phase 4

• 1 other identifier: Rifaximin and Nutrition
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Markers of improvement in general health

  Participants will be followed for 180 days

Study Arms (2)

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.

Drug: Lactulose; Drug: Rifaximin Placebo

Rifaximin and Lactulose Placebo

ACTIVE COMPARATOR

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

Drug: Rifaximin; Drug: Lactulose Placebo

Interventions

Rifaximin DRUG

Rifaximin 550mg by mouth twice a day

Also known as: Xifaxan

Rifaximin and Lactulose Placebo

Lactulose DRUG

Lactulose 30ml by mouth three times a day

Also known as: Enulose, Generlac, Cholac, Constulose, Kristalose, Laxilose, Portalac, Hepatalac, Constilac

Lactulose and Rifaximin Placebo

Lactulose Placebo DRUG

Lactulose Placebo 30ml three times a day

Rifaximin and Lactulose Placebo

Rifaximin Placebo DRUG

Rifaximin Placebo twice a day

Also known as: Sugar Pill

Lactulose and Rifaximin Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Tampa General Hospital: lead

Study Sites (1)

Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Hypertension, Portal

Interventions

Rifaximin; Lactulose; Sugars

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Guy Neff, MD, MBA

  Tampa General Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2014
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (1)