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Probiotics for the Prevention of Major Complications of Cirrhosis

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ClinicalTrials.gov Identifier: NCT00312910
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : May 22, 2008
Sponsor:
Collaborator:
Ambrosia - SupHerb Ltd.
Information provided by:
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Probiotics-Bio-plus Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Probiotics for the Prevention of Major Complications of Cirrhosis
Study Start Date : April 2005
Actual Study Completion Date : October 2007





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

Secondary Outcome Measures :
  1. Hospital Admissions due to complications of cirrhosis
  2. Ammonia blood levels
  3. Hepatic and renal function


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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Exclusion Criteria:

  1. Patients with alcoholic cirrhosis who still consume alcohol
  2. Patients that are chronically treated with antibiotics or lactulose -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312910


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