Effect of probiotic, VSL#3 on portal pressure in patients with cirrhosis
- Conditions
- Health Condition 1: null- Cirrhotic patients with increased portal pressure and large varices
- Registration Number
- CTRI/2009/091/000211
- Lead Sponsor
- Dept of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Consecutive patients of cirrhosis with portal hypertension who fulfill the following criteria:
1.Diagnosed cases of cirrhosis (by clinical, biochemical and radiological criteria with or without liver biopsy)
2.No history of upper GI bleeding in the past
3.Endoscopically documented large esophageal varices
Exclusion criteria
1.history of gastrointestinal bleeding
2.patients who have received beta blockers for portal hypertension in the past 6 weeks.
3.hepatic encephalopathy
4.ongoing bacterial infection,
5.Spontaneous bacterial peritonitis
6.active alcoholism or illicit drug abuse
7.alcoholic hepatitis
8.Treatment with antibiotics in the preceding 2 weeks.
9.presence of hepatocellular carcinoma,
10.portal vein thrombosis
11.serum creatinine>1.5 mg/dL,
12.treatment with vasoactive drugs in the past 6 weeks,
13.history of arterial hypertension, congestive heart failure or arterial occlusive disease, and
14.Refusal to participate.
15.Active smokers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Primary <br/ ><br>a.Change in HVPG levels as compared with baseline, to define responder (more than or equal to 20% reduction in HVPG or to less than or equal to 12 mm Hg). <br/ ><br>Timepoint: 2 months
- Secondary Outcome Measures
Name Time Method 2.Secondary<br>a.Reduction in serum and hepatic endotoxin and cytokine levels <br>b.Assessment of improvement in the renal parameters and Systemic inflammatory response syndrome<br>c.Improvement in the markers of oxidative injury<br>d.Adverse effects<br>Timepoint: 2 months