Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

NCT ID: NCT01218568

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

Brief Summary

The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.

Conditions

Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rifaximin plus lactulose

Group Type: EXPERIMENTAL

Rifaximin plus lactulose

Intervention Type: DRUG

Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.

lactulose

30-60ml/day

Group Type: ACTIVE_COMPARATOR

Lactulose

Intervention Type: DRUG

Lactulose 30-60 ml in two or three divided doses.

Interventions

Rifaximin plus lactulose

Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.

Intervention Type: DRUG

Lactulose

Lactulose 30-60 ml in two or three divided doses.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Cirrhosis
• Age 18-80
• Hepatic encephalopathy grade II-IV
• Informed consent

Exclusion Criteria

1. Degenerative CNS disease or major psychiatric illness

2. Serum creatinine > 1.5 mg/dl

3. Active alcohol intake <4 weeks prior to present episode

4. Others metabolic encephalopathies

5. Hepatocellular Carcinoma

6. Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS HE-01

Identifier Type: -

Identifier Source: org_study_id