search
Back to results

Probiotics for the Prevention of Major Complications of Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Probiotics-Bio-plus
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis focused on measuring Cirrhosis, Probiotics, Hepatic encephalopathy, Ammonia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Meir Medical Center

Outcomes

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

Full Information

First Posted
April 9, 2006
Last Updated
May 21, 2008
Sponsor
Meir Medical Center
Collaborators
Ambrosia - SupHerb Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00312910
Brief Title
Probiotics for the Prevention of Major Complications of Cirrhosis
Official Title
Probiotics for the Prevention of Major Complications of Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meir Medical Center
Collaborators
Ambrosia - SupHerb Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Cirrhosis, Probiotics, Hepatic encephalopathy, Ammonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Probiotics-Bio-plus
Primary Outcome Measure Information:
Title
The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)
Secondary Outcome Measure Information:
Title
Hospital Admissions due to complications of cirrhosis
Title
Ammonia blood levels
Title
Hepatic and renal function

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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: Patients with alcoholic cirrhosis who still consume alcohol Patients that are chronically treated with antibiotics or lactulose -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pereg, MD
Organizational Affiliation
Meir Medical Center, Kfar-Sava, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yona Kitay-Cohen, MD
Organizational Affiliation
Meir Medical Center, Kfar-Sava, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Sava
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15122774
Citation
Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology. 2004 May;39(5):1441-9. doi: 10.1002/hep.20194.
Results Reference
background
PubMed Identifier
15761413
Citation
Pereg D, Kimhi O, Tirosh A, Orr N, Kayouf R, Lishner M. The effect of fermented yogurt on the prevention of diarrhea in a healthy adult population. Am J Infect Control. 2005 Mar;33(2):122-5. doi: 10.1016/j.ajic.2004.11.001.
Results Reference
background
PubMed Identifier
11241043
Citation
Szajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. doi: 10.1067/mpd.2001.111321.
Results Reference
background
PubMed Identifier
10634221
Citation
Pochapin M. The effect of probiotics on Clostridium difficile diarrhea. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S11-3. doi: 10.1016/s0002-9270(99)00809-6.
Results Reference
background

Learn more about this trial

Probiotics for the Prevention of Major Complications of Cirrhosis

We'll reach out to this number within 24 hrs