Quality of Life and Nutritional Improvements in Cirrhotic Patients

Tampa General Hospital (TGH)

Status and phase: Terminated; Phase 4

Conditions: Portal Hypertension; Hepatic Encephalopathy; Liver Cirrhosis

Treatments: Drug: Rifaximin Placebo; Drug: Rifaximin; Drug: Lactulose Placebo; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01842113

Rifaximin and Nutrition

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups

Lactulose and Rifaximin Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Lactulose

Drug: Rifaximin Placebo

Rifaximin and Lactulose Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Lactulose Placebo

Drug: Rifaximin