A Phase 4 interventional study of Rifaximin and Lactulose in Liver Cirrhosis, Hepatic Encephalopathy and Portal Hypertension, sponsored by Tampa General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-23.
Sponsored by Tampa General Hospital · Phase 4, Interventional, and Treatment
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).
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Tampa General Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day.
Drug: Lactulose · Drug: Rifaximin Placebo
Rifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day.
Drug: Rifaximin · Drug: Lactulose Placebo
Rifaximin 550mg by mouth twice a day
Also known as: Xifaxan
Lactulose 30ml by mouth three times a day
Also known as: Enulose, Generlac, Cholac, Constulose, Kristalose, Laxilose, Portalac, Hepatalac, Constilac
Lactulose Placebo 30ml three times a day
Rifaximin Placebo twice a day
Also known as: Sugar Pill
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).
Time frame: Participants will be followed for 180 days
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.
Time frame: Participants will be followed for 180 days
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.
Time frame: Participants will be followed for 180 days
This study is terminated, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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