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Probiotics for Portal Hypertension

Govind Ballabh Pant Hospital
ClinicalTrials.gov · Datasets · License: Public Domain
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cirrhosis
Chronic peripheral and splanchnic vasodilatation are the hallmark hemodynamic abnormality in cirrhosis and contribute to the pathogenesis of portal hypertension. Alterations in intestinal motility and bacterial overgrowth in gut may predispose to the development of bacteraemia and endotoxaemia in cirrhotic patients which play a role in the hyperdynamic circulatory syndrome of cirrhosis. Probiotic therapy is aimed at changing the make-up of the indigenous microflora by administering specific strains of non-pathogenic and potentially beneficial microflora. In this study, the investigators hypothesize that a modification in the composition of the endogenous digestive microflora by oral bacteriotherapy with high potency probiotic preparations could be a safe way to regulate the portal pressure. As there is a relative paucity in effective pharmacological treatment for portal hypertension, these novel and innovative therapy might provide important alternative or adjunct therapy to beta blockers in the clinical management of patients with portal hypertension. Aims and objectives To study in patients with cirrhosis and large varices whether probiotics and/or norfloxacin given for 2 months : 1. achieve a reduction in HVPG 2. alter the endotoxin and cytokine levels, and improve systemic inflammatory responses 3. well tolerated. 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 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. Treatmen
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