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Sponsors and Collaborators: |
Meir Medical Center Ambrosia - SupHerb Ltd. |
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Information provided by: | Meir Medical Center |
ClinicalTrials.gov Identifier: | NCT00312910 |
The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.
Condition | Intervention |
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Liver Cirrhosis |
Drug: Probiotics-Bio-plus |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Probiotics for the Prevention of Major Complications of Cirrhosis |
Estimated Enrollment: | 50 |
Study Start Date: | April 2005 |
Study Completion Date: | October 2007 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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Exclusion Criteria:
Israel | |
Meir Medical Center | |
Kfar-Sava, Israel |
Principal Investigator: | David Pereg, MD | Meir Medical Center, Kfar-Sava, Israel |
Principal Investigator: | Yona Kitay-Cohen, MD | Meir Medical Center, Kfar-Sava, Israel |
Study ID Numbers: | MeirMc-05DP2907-CTIL |
Study First Received: | April 9, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00312910 History of Changes |
Health Authority: | Israel: Ethics Commission |
Cirrhosis Probiotics Hepatic encephalopathy Ammonia |
Liver Diseases Hepatic Encephalopathy Digestive System Diseases Fibrosis Liver Cirrhosis |
Liver Diseases Pathologic Processes Digestive System Diseases Fibrosis Liver Cirrhosis |