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Probiotics for the Prevention of Major Complications of Cirrhosis
This study has been completed.
Sponsors and Collaborators: Meir Medical Center
Ambrosia - SupHerb Ltd.
Information provided by: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00312910
  Purpose

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


Condition Intervention
Liver Cirrhosis
Drug: Probiotics-Bio-plus

MedlinePlus related topics: Cirrhosis
Drug Information available for: Ammonia
U.S. FDA Resources
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

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)

Secondary Outcome Measures:
  • Hospital Admissions due to complications of cirrhosis
  • Ammonia blood levels
  • Hepatic and renal function

Estimated Enrollment: 50
Study Start Date: April 2005
Study Completion Date: October 2007
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Patients with alcoholic cirrhosis who still consume alcohol
  2. Patients that are chronically treated with antibiotics or lactulose -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312910

Locations
Israel
Meir Medical Center
Kfar-Sava, Israel
Sponsors and Collaborators
Meir Medical Center
Ambrosia - SupHerb Ltd.
Investigators
Principal Investigator: David Pereg, MD Meir Medical Center, Kfar-Sava, Israel
Principal Investigator: Yona Kitay-Cohen, MD Meir Medical Center, Kfar-Sava, Israel
  More Information

Publications:
Study ID Numbers: MeirMc-05DP2907-CTIL
Study First Received: April 9, 2006
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00312910  
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Cirrhosis
Probiotics
Hepatic encephalopathy
Ammonia

Study placed in the following topic categories:
Liver Diseases
Hepatic Encephalopathy
Digestive System Diseases
Fibrosis
Liver Cirrhosis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009