Suspended

Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.

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What is being tested

Lactulose

+ Rifaximin Placebo

+ Rifaximin

Drug
Who is being recruted

Brain Diseases+13

+ Brain Diseases, Metabolic

+ Central Nervous System Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorTampa General Hospital
Last updated: September 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01842113
Principal SponsorTampa General Hospital
Last updated: September 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesDigestive System DiseasesFibrosisLiver DiseasesMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyHepatic EncephalopathyHypertension, PortalLiver Cirrhosis

Criteria

6 inclusion criteria required to participate
Conn Score < 2
Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis
Male and female gender of Age 18 years or older
Model for End Stage Liver Disease (MELD) score < 20
Show More Criteria
11 exclusion criteria prevent from participating
Active alcohol consumption
Any of the following diagnoses
Evidence of severe concomitant illness or any condition that makes them unsuitable for the study in the opinion of the investigator(s)
HIV
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Tampa General Medical Group

Tampa, United StatesOpen Tampa General Medical Group in Google Maps
SuspendedOne Study Center