search
Back to results

Quality of Life and Nutritional Improvements in Cirrhotic Patients

Primary Purpose

Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Lactulose
Lactulose Placebo
Rifaximin Placebo
Sponsored by
Tampa General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lactulose and Rifaximin Placebo

Rifaximin and Lactulose Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 11, 2013
Last Updated
September 20, 2013
Sponsor
Tampa General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01842113
Brief Title
Quality of Life and Nutritional Improvements in Cirrhotic Patients
Official Title
Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
PI Initiated study - PI left facility
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampa General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactulose and Rifaximin Placebo
Arm Type
Active Comparator
Arm Description
Standard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day.
Arm Title
Rifaximin and Lactulose Placebo
Arm Type
Active Comparator
Arm Description
Rifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxan
Intervention Description
Rifaximin 550mg by mouth twice a day
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Enulose, Generlac, Cholac, Constulose, Kristalose, Laxilose, Portalac, Hepatalac, Constilac
Intervention Description
Lactulose 30ml by mouth three times a day
Intervention Type
Drug
Intervention Name(s)
Lactulose Placebo
Intervention Description
Lactulose Placebo 30ml three times a day
Intervention Type
Drug
Intervention Name(s)
Rifaximin Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Rifaximin Placebo twice a day
Primary Outcome Measure Information:
Title
Outcomes of Change in Quality of Life Assessment Between the Two Groups
Description
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).
Time Frame
Participants will be followed for 180 days
Title
Nutritional Improvement Between the Two Groups
Description
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.
Time Frame
Participants will be followed for 180 days
Secondary Outcome Measure Information:
Title
Markers of improvement in general health
Description
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.
Time Frame
Participants will be followed for 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Neff, MD, MBA
Organizational Affiliation
Tampa General Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quality of Life and Nutritional Improvements in Cirrhotic Patients

We'll reach out to this number within 24 hrs