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Completed

NCT Number: NCT01218568

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110 070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin plus lactulose

Drug

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

Lactulose

Drug

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

Primary outcomes

  1. Reversal of hepatic encephalopathy

    Time frame: 10 days

Secondary outcomes

  1. Death

    Time frame: 10 days

  2. duration of hospital stay

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2010
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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