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

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Hepatic Encephalopathy

Treatments

Drug: Lactulose

Drug: Rifaximin plus lactulose

Study type

Interventional

Funder types

Other

Identifiers

NCT01218568

ILBS HE-01

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Degenerative CNS disease or major psychiatric illness
Serum creatinine > 1.5 mg/dl
Active alcohol intake <4 weeks prior to present episode
Others metabolic encephalopathies
Hepatocellular Carcinoma
Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life