The study of effects of Probiotic lactobacilli in Preventing Major Complications in patients of Liver Cirrhosis.
Phase 4
Completed
- Registration Number
- CTRI/2010/091/001321
- Lead Sponsor
- nique Biotech, Chennai, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of complications of liver cirrhosis, during the treatment periodTimepoint: From beginning to end of the study
- Secondary Outcome Measures
Name Time Method 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