Clinical trial NCT01842113: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Liver Cirrhosis
Hepatic Encephalopathy
Portal Hypertension
Lead sponsor: Tampa General Hospital
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Outcomes of Change in Quality of Life Assessment Between the Two Groups
timeFrame: Participants will be followed for 180 days
measure: Nutritional Improvement Between the Two Groups
timeFrame: Participants will be followed for 180 days
Secondary outcomes:
measure: Markers of improvement in general health
timeFrame: Participants will be followed for 180 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
Study officials:
affiliation: Tampa General Medical Group
name: Guy Neff, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: