To compare the efficacy of rifaximin and lactulose in improving minimal hepatic encephalopathy in patients with cirrhosis: a single blind, randomised, active-comparator, non-inferiority trial - (ALARM: Active Comparator Trial of Lactulose & Rifaximin In MHE)

Department of Gastroenterology0 个研究点目标入组 112 人开始时间: 待定最近更新: 2021年11月24日

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•Age 18-65 years
•-Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and/or liver histology data.
•-Minimal hepatic encephalopathy diagnosed by abnormalities in psychometric tests

•-Known allergy to rifaximin/rifabutin or lactulose.
•-Current or recent (< 6 weeks) use of alcohol
•-Use of antibiotics within last 6 weeks
•-Use of lactulose, lactitol, L-ornithine L-aspartate, zinc, metronidazole, neomycin, or rifaximin within the last 6 weeks
•-Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks
•-Infection or gastrointestinal haemorrhage within the last 6 weeks
•-Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance
•-Hepatocellular carcinoma
•-History of porto-systemic shunt surgery or transjugular intrahepatic portosystemic shunt (TIPS)
•-Pregnancy and breastfeeding
•-Neurological or psychiatric problems which may influence quality of life measurement.
•-Poor vision or motor defects which interfere with the performance of psychometric tests.
•-Current or recent (< 6 months) history of overt hepatic encephalopathy. This would be excluded by:
•oDetailed history taking from patient, friends/relatives
•oDetailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
•oFocus on lack of awareness, alertness, anxiety or euphoria (To rule out grade 1 hepatic encephalopathy)
•oMini-mental status examination score > 25
•-Women of child-bearing potential who is not using two effective methods of contraception.

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