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Quality of Life and Nutritional Improvements in Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT01842113
Recruitment Status : Terminated (PI Initiated study - PI left facility)
First Posted : April 29, 2013
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
Guy Neff, MD, 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).

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Hepatic Encephalopathy Portal Hypertension Drug: Rifaximin Drug: Lactulose Drug: Lactulose Placebo Drug: Rifaximin Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.
Study Start Date : April 2013
Estimated Primary Completion Date : May 2014


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 Name: 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 Name: Xifaxan

Drug: Lactulose Placebo
Lactulose Placebo 30ml three times a day




Primary Outcome Measures :
  1. Outcomes of Change in Quality of Life Assessment Between the Two Groups [ Time Frame: 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).

  2. Nutritional Improvement Between the Two Groups [ Time Frame: 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 :
  1. Markers of improvement in general health [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842113


Locations
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United States, Florida
Tampa General Medical Group
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Tampa General Hospital
Investigators
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Principal Investigator: Guy Neff, MD, MBA Tampa General Medical Group
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Responsible Party: Guy Neff, MD, Medical Doctor, Tampa General Hospital
ClinicalTrials.gov Identifier: NCT01842113    
Other Study ID Numbers: Rifaximin and Nutrition
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Lactulose
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents