Role of a probiotic, VSL#3, in the prevention of spontaneous bacterial peritonitis
- Conditions
- Health Condition 1: null- Primary and secondary prophylaxis of patients with Spontaneous Bacterial Peritonitis
- Registration Number
- CTRI/2008/091/000079
- Lead Sponsor
- Dept of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 250
•All patients with liver cirrhosis with ascites having either history of prior SBP or ascitic fluid protein <1 gm/dl will be included in the study irrespective of etiology.
•Cirrhosis will be diagnosed on the basis of clinical, radiological and/or histological ground Patients will be evaluated with complete medical history, clinical examination and baseline laboratory parameters: liver function test, renal function test, ascitic fluid analysis and disease specific further investigations as required. Cirrhosis will be classified according to Childâ??s-Pugh classification system.
-Patients chronically treated with antibiotics (that disturb/alter normal gut flora) or lactulose during past 30 days.
-Patients having risk factor of small intestinal bacterial overgrowth other than cirrhosis - diabetes mellitus, history of abdominal surgery, immunomodulatory drugs, Alcoholic cirrhotics who continue to take alcohol.
-Patients with active or recent G.I. bleed (within prior 7 days).
-Patients with advanced HCC, renal failure and portal vein thrombosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.No. of SBP episodes in one year<br>2.Time for development of an episode of SBP in 1 year<br>3.Time to mortality (Survival time)<br>4. Mortality<br>Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method 1. Histology (if available, not mandatory for all patients)<br>2. Liver Enzymes<br>3. Hepatic encephalopathy<br>4. Variceal bleeding<br>5. Renal statusTimepoint: 1 year