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The study of effects of Probiotic lactobacilli in Preventing Major Complications in patients of Liver Cirrhosis.

The study of effects of Probiotic lactobacilli in Preventing Major Complications in patients of Liver Cirrhosis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001321
Enrollment
60
Registered
2010-11-19
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

None listed

Interventions

Intervention1: Probiotic lactobacilli: 2 Billion CFU/cap Twice daily Control Intervention1: Placebo: One Capsule twice daily

Sponsors

Unique Biotech, Chennai, India
Lead Sponsor
Associate Pharma., Mumbai, India.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age: 30 to 50 years Sex: both Patient with sonographically confirmed diagnosis of cirrhosis Patients with liver cirrhosis with the history of major complication of cirrhosis (including variceal bleeding, encephalopathy and spontaneous bacterial peritonitis) Evidence for portal hypertension

Exclusion criteria

Exclusion criteria: Patients with alcoholic cirrhosis who still consume alcohol Patients having risk factor of small intestinal bacterial overgrowth other than cirrhosis - diabetes mellitus, history of abdominal surgery, immunomodulator drugs Patients with active or recent G.I. bleeding (within prior 7 days) Patients with advanced hepatocellular carcinoma, renal failure and portal vein thrombosis

Design outcomes

Primary

MeasureTime frame
Incidence of complications of liver cirrhosis, during the treatment periodTimepoint: From beginning to end of the study

Secondary

MeasureTime frame
DeathTimepoint: From beginning to end of the study;Hospital admissions due to cirrhosis complicationsTimepoint: From beginning to end of the study;Liver function testsTimepoint: Visit1, Visit2 and Visit3;Renal Function testsTimepoint: Visit1, Visit2 and Visit3;Serum ammoniaTimepoint: Visit 1, visit 2 and visit3

Countries

India

Contacts

Public ContactDr Pardeshi M L
narayanburte@yahoo.com02026126010

Outcome results

None listed

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