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

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)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003045

Enrollment

112

Registered

2011-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cirrhosis with minimal hepatic encephalopathy

Interventions

Intervention1: Rifaximin tablets: 400 mg thrice a day, per oral Control Intervention1: Lactulose syrup: 30-90 ml per day in divided doses, per oral

Eligibility

Inclusion criteria

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

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: o Detailed history taking from patient, friends/relatives o Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation o Focus on lack of awareness, alertness, anxiety or euphoria (To rule out grade 1 hepatic encephalopathy) o Mini-mental status examination score > 25 -Women of child-bearing potential who is not using two effective methods of contraception.

Design outcomes

Primary

Measure	Time frame
Improvement in psychometric test performance.Timepoint: 3 months	—

Secondary

Measure	Time frame
Improvement in health related quality of lifeTimepoint: 3 months;Tolerability of rifaximin and lactuloseTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Sandeep S Sidhu

Professor

dmcgastro@in.com01614687340

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026