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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Encephalopathy
• Intervention / Treatment: Drug: Rifaximin plus lactulose; Drug: Lactulose

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110 070
      • Institute of Liver & Biliary Sciences (ILBS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifaximin plus lactulose	Drug: Rifaximin plus lactulose; Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
Active Comparator: lactulose; 30-60ml/day	Drug: Lactulose; Lactulose 30-60 ml in two or three divided doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reversal of hepatic encephalopathy	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	10 days
duration of hospital stay	10 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 2, 2013
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: ILBS HE-01