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Rifaximin Versus Lactulose in Renal Failure

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00748904
Enrollment
0
Registered
2008-09-09
Start date
2008-06-30
Completion date
2009-07-31
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Renal Failure

Keywords

cirrhosis of liver and progressive renal failure

Brief summary

The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.

Interventions

DRUGRifaximin

400 mg orally

DRUGLactulose

20 grams titrate to 2-3 bowel movements in one day

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* cirrhosis of liver of any etiology * progressive renal failure * stage 0-2 hepatic encephalopathy

Exclusion criteria

* pregnant women

Design outcomes

Primary

MeasureTime frame
slower progression to severe hepatic encephalopathy, stage 3 or 4during hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026