NCT00808990

The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Probiotics and Non Alcoholic Steatohepatitis (NASH)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of chronic liver disease in the general population in the Western World. In advanced stages of NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of probiotics as a therapeutic strategy for this disorder.

Detailed description

Probiotics may interfere with the development of NASH by several mechanisms. Data from an uncontrolled clinical trial in NASH patients show promising results, with improvement of liver enzymes in treated patients. RESEARCH GOALS: A. To assess the degree of SIBO in NAFLD patients vs. healthy controls. B. To evaluate the effect of probiotics vs. placebo on SIBO in NAFLD patients. C. To evaluate the effect of probiotics vs. placebo on disease severity (inflammation, steatosis, and fibrosis) in NAFLD patients.

Conditions

• Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BioFemale	BioFemale 6 months.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2008-12-16
• Last updated: 2016-04-08

Locations

1 site across 1 country: Israel