Quality of Life and Nutritional Improvements in Cirrhotic Patients

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01842113
• Other study ID #: Rifaximin and Nutrition
• Status: Terminated
• Phase: Phase 4
• First received: April 11, 2013
• Last updated: September 20, 2013
• Start date: April 2013

Study information

• Verified date: September 2013
• Source: Tampa General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Rifaximin
Rifaximin 550mg by mouth twice a day
• Lactulose
Lactulose 30ml by mouth three times a day
• Lactulose Placebo
Lactulose Placebo 30ml three times a day
• Rifaximin Placebo
Rifaximin Placebo twice a day

Locations

Country	Name	City	State
United States	Tampa General Medical Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tampa General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No