Quality of Life and Nutritional Improvements in Cirrhotic Patients

NCT01842113 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-09-23

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842113 on ClinicalTrials.gov