RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Neurology, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2006 |
| Contact: | Lennox J. Jeffers, MD |
| Email: | LJeffers@med.miami.edu |
| Phone: | 305-243-5787 |
The purpose of this study is to compare the effectiveness of three different treatments for
hepatic encephalopathy. These treatments are:
- Group 1 - lactulose given with a rifaximin placebo (sugar pill)
- Group 2 - lactulose given with rifaximin
- Group 3 - rifaximin given alone
The goals of this study are to determine which treatment is most effective at (1) reducing
admissions to hospital for hepatic encephalopathy and (2) improving mental function, during
the study period.
hepatic encephalopathy. These treatments are:
- Group 1 - lactulose given with a rifaximin placebo (sugar pill)
- Group 2 - lactulose given with rifaximin
- Group 3 - rifaximin given alone
The goals of this study are to determine which treatment is most effective at (1) reducing
admissions to hospital for hepatic encephalopathy and (2) improving mental function, during
the study period.
Background:
Hepatic encephalopathy (HE) is a reversible process resulting from advanced liver disease.
It can range in severity from disturbed sleep patterns to profound coma and can be triggered
by a number of common factors, including intestinal bleeding, infection, constipation, and
dietary changes.
This study will compare two different medications, used alone or in combination, to prevent
relapses of HE. Lactulose is a laxative (causes increased bowel movements) which has been
widely used in the treatment of HE. However, it is not clear how effective it is for this
purpose and is not always well tolerated. Rifaximin is an oral antibiotic which has been
studied in the treatment of HE, including longer treatment courses but its role in the
prevention of HE relapses is not clear. No studies to date have compared the use of
lactulose to combination treatment with lactulose and rifaximin in the prevention of
recurrent episodes of HE.
Study Overview:
This study is a single-center, randomized, controlled trial evaluating the efficacy and
safety of rifaximin, given alone or in combination with lactulose, as compared to lactulose
given alone, in subjects in remission from prior acute episodes of HE. This study seeks
specifically to examine the role of combination treatment with rifaximin and lactulose, as
compared to either treatment alone, in maintaining remission of HE.
Our study hypothesis is that rifaximin, given alone or in combination with lactulose, will
reduce the number of hospital admissions for acute HE, and will improve overall mental
function during the treatment period, relative to standard lactulose therapy.
This is a double-blinded study (for rifaximin only), which means that neither you nor your
study doctor will know whether you are being treated with rifaximin or a placebo pill. You
will, however, know whether you are receiving lactulose.
Hepatic encephalopathy (HE) is a reversible process resulting from advanced liver disease.
It can range in severity from disturbed sleep patterns to profound coma and can be triggered
by a number of common factors, including intestinal bleeding, infection, constipation, and
dietary changes.
This study will compare two different medications, used alone or in combination, to prevent
relapses of HE. Lactulose is a laxative (causes increased bowel movements) which has been
widely used in the treatment of HE. However, it is not clear how effective it is for this
purpose and is not always well tolerated. Rifaximin is an oral antibiotic which has been
studied in the treatment of HE, including longer treatment courses but its role in the
prevention of HE relapses is not clear. No studies to date have compared the use of
lactulose to combination treatment with lactulose and rifaximin in the prevention of
recurrent episodes of HE.
Study Overview:
This study is a single-center, randomized, controlled trial evaluating the efficacy and
safety of rifaximin, given alone or in combination with lactulose, as compared to lactulose
given alone, in subjects in remission from prior acute episodes of HE. This study seeks
specifically to examine the role of combination treatment with rifaximin and lactulose, as
compared to either treatment alone, in maintaining remission of HE.
Our study hypothesis is that rifaximin, given alone or in combination with lactulose, will
reduce the number of hospital admissions for acute HE, and will improve overall mental
function during the treatment period, relative to standard lactulose therapy.
This is a double-blinded study (for rifaximin only), which means that neither you nor your
study doctor will know whether you are being treated with rifaximin or a placebo pill. You
will, however, know whether you are receiving lactulose.
Inclusion Criteria:
- Cirrhosis of any cause
- History of previous admission for acute HE within 1 year of screening
Exclusion Criteria:
- History of allergy to lactulose or rifaximin.
- Ongoing alcohol or drug dependence
- Required use of sedatives or narcotics
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