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Quality of Life and Nutritional Improvements in Cirrhotic Patients

NCT ID: NCT01842113

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis Hepatic Encephalopathy Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lactulose and Rifaximin Placebo

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

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

Lactulose 30ml by mouth three times a day

Rifaximin Placebo

Intervention Type DRUG

Rifaximin Placebo twice a day

Rifaximin and Lactulose Placebo

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

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Rifaximin 550mg by mouth twice a day

Lactulose Placebo

Intervention Type DRUG

Lactulose Placebo 30ml three times a day

Interventions

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Rifaximin

Rifaximin 550mg by mouth twice a day

Intervention Type DRUG

Lactulose

Lactulose 30ml by mouth three times a day

Intervention Type DRUG

Lactulose Placebo

Lactulose Placebo 30ml three times a day

Intervention Type DRUG

Rifaximin Placebo

Rifaximin Placebo twice a day

Intervention Type DRUG

Other Intervention Names

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Xifaxan Enulose Generlac Cholac Constulose Kristalose Laxilose Portalac Hepatalac Constilac Sugar Pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampa General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guy Neff, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Neff, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Tampa General Medical Group

Locations

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Tampa General Medical Group

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Rifaximin and Nutrition

Identifier Type: -

Identifier Source: org_study_id