Quality of Life and Nutritional Improvements in Cirrhotic Patients
NCT01842113 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2013-09-23
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).
Conditions
- Liver Cirrhosis
- Hepatic Encephalopathy
- Portal Hypertension
Interventions
- DRUG
-
Rifaximin
Rifaximin 550mg by mouth twice a day
- DRUG
-
Lactulose
Lactulose 30ml by mouth three times a day
- DRUG
-
Lactulose Placebo
Lactulose Placebo 30ml three times a day
- DRUG
-
Rifaximin Placebo
Rifaximin Placebo twice a day
Sponsors & Collaborators
-
Tampa General Hospital
lead OTHER
Principal Investigators
-
Guy Neff, MD, MBA · Tampa General Medical Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-05-31
Countries
- United States
Study Locations
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