Probiotics for the Prevention of Major Complications of Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Probiotics for the Prevention of Major Complications of Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312910
• Other study ID #: MeirMc-05DP2907-CTIL
• Status: Completed
• Phase: N/A
• First received: April 9, 2006
• Last updated: May 21, 2008
• Start date: April 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2007
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Drug:
• Probiotics-Bio-plus

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Sava

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Ambrosia - SupHerb Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View Citation

Pochapin M. The effect of probiotics on Clostridium difficile diarrhea. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S11-3. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)
Secondary	Hospital Admissions due to complications of cirrhosis
Secondary	Ammonia blood levels
Secondary	Hepatic and renal function