Probiotics for the Prevention of Major Complications of Cirrhosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.

Detailed Description
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Colonic bacteria clearly play a major role in the pathogenesis of major complications in patients with liver cirrhosis. By producing ammonia and endotoxins they can cause hepatic encephalopathy , and their translocation from the gut to the peritoneal cavity is the major mechanism for spontaneous bacterial peritonitis. There are also new studies suggesting a possible connection between bacterial translocation and bleeding from esophageal varices. Some of the therapeutic measures for the treatment and prevention of complications in cirrhotic patients, such as antibiotics and lactulose, are partially directed against gut bacteria. In recent years there is a growing interest in the effect of probiotic bacteria on gut flora and prevention of infection. They were found to prevent pediatric infectious diarrhea and antibiotic-associated diarrhea- especially those caused by Clostridium difficile. The probiotic bacteria, among which the most common are the lactose fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the gut mucosa and by that are thought to prevent bacterial translocation from the gut. These effects of probiotics raised the idea that they may have a role in the treatment and prevention of cirrhosis complications. A recent study examined the effect of probiotics on patients with minimal chronic hepatic encephalopathy. Hepatic encephalopathy was reversed in 50% of the patients receiving probiotics. These patients also demonstrated a significant reduction of blood levels of ammonia, bilirubin and ALT, and of pathologic bacteria in stool cultures. This study showed promising results but was carried out on a relatively small population. Furthermore, the effect of probiotics on the prevention of hepatic encephalopathy and other major complications of cirrhosis has not been studied yet. Therefore, more studies are needed to establish the role of probiotics in patients with cirrhosis.

Official Title
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Probiotics for the Prevention of Major Complications of Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Probiotics-Bio-plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with liver cirrhosis with at least one of the followings 1)Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function - Exclusion Criteria: Patients with alcoholic cirrhosis who still consume alcohol Patients that are chronically treated with antibiotics or lactulose -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Probiotics-Bio-plus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions due to complications of cirrhosis |  |  | 
| Ammonia blood levels |  |  | 
| Hepatic and renal function |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Probiotics, Hepatic encephalopathy, Ammonia