A clinical trial to compare Rifaximin with Lactulose in improving psychometric test performance in patients with cirrhosis and minimal hepatic encephalopathy.

Phase 4

Completed

• Conditions: Health Condition 1: null- Cirrhosis with minimal hepatic encephalopathy

• Registration Number: CTRI/2010/091/003045
• Lead Sponsor: Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified