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â??PREVENTION OF HEPATIC ENCEPHALOPATHY IN PATIENTS WITH LIVER CIRRHOSISâ??

â??AN OPEN LABEL RANDOMISED CONTROLLED TRIAL OF PROBIOTICS FOR PRIMARY PROPHYLAXIS OF HEPATIC ENCEPHALOPATHY IN PATIENTS WITH CIRRHOSISâ??

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002807
Enrollment
100
Registered
2012-07-16
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- patients with cirrhosis with no previous overt hepatic encephalopathy

Interventions

Intervention1: probiotic: VSL#3, 110billion CFU each capsule per oral, three times a day, along with other usual medication for six months Control Intervention1: placebo: patienst will be continued on

Sponsors

G B Pant Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cirrhotic patients, age 18-75 years. No history of overt hepatic encephalopathy

Exclusion criteria

Exclusion criteria: Patients on lactulose therapy History of recent alcohol intake (in past 4 weeks) Recent infection or antibiotic use (in past 6 weeks) Patients on secondary prophylaxis for spontaneous bacterial peritonitis Recent G I bleeding Hepatocellular carcinoma Previous TIPS and shunt surgeries Use of psychotropic drugs which may affect psychometric tests Any neurologic disease such as Alzheimerâ??s disease, Parkinsonâ??s disease and nonhepatic metabolic encephalopathies Significant heart, respiratory or renal failure

Design outcomes

Primary

MeasureTime frame
development of overt hepatic encephalopathy in two groupsTimepoint: six months after recruitment of last patient in the study

Secondary

MeasureTime frame
Baseline psychometric test, critical flicker frequency (CFF), SIBO, oro-cecal transit time and blood ammonia level as predictor of development of hepatic encephalopathy.Timepoint: 6 month after recruitment of last patient

Countries

India

Contacts

Public ContactDr B C Sharma

G B Pant Hospital

manishlunia@gmail.com9718599211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 22, 2026