Health Condition 1: null- Cirrhotic patients with increased portal pressure and large varices
Conditions
Interventions
Intervention1: VSL#3 Alone (Patients contraindicated to beta blockers
Independent arm): VSL#3 dose = 900 billion CFU/ day
Duration = 2 months
Intervention2: Beta Blockers + VSL#3: Dose of Beta blockers as decided by investigator, VSL#3 dose = 900 billion CFU/ day
Duration = 2 months
Control Intervention1: Beta Blockers alone: Dose decided by investigator
Duration = 2 months
Control Intervention2: Beta Blockers + Norfloxacin: Dose of Beta blockers as decided by investigator, Norfloxacin dose = 400 mg BD, Duration = 2 months
Sponsors
Dept of Gastroenterology
Cytokine kits and study drugs
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary 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). Timepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Secondary a. Reduction in serum and hepatic endotoxin and cytokine levels b. Assessment of improvement in the renal parameters and Systemic inflammatory response syndrome c. Improvement in the markers of oxidative injury d. Adverse effects Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactProf S K Sarin
GB Pant Hospital, Affiliated to the University of Delhi
Outcome results
None listed