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Sponsored by: |
Rabin Medical Center |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00808990 |
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.
Condition | Intervention |
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Liver Disease |
Dietary Supplement: probiotics: BioFemale by SOLGAR Israel, SupHerb) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Probiotics and Non Alcoholic Steatohepatitis (NASH) |
Estimated Enrollment: | 120 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Use instructions: before breakfast 2 pills followed by cold drink or food.
Probiotics: Each pill contains 10x10^9 of the following bacteria:
Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus casei, Streptococcus thermophilus. All participants will receive either probiotics or placebo pills blindly for six months.
All participants will receive either probiotics or placebo pills blindly for six months.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Controls
NAFLD group
Contact: Hemda Weiss, M.D. | 97239372305 ext 2580 | hemdaw@clalit.org.il |
Israel | |
Rabin Medical Center | |
Petach Tikva, Israel, 49100 |
Principal Investigator: | Hemda Weiss, M.D. | Rabin Medical Center |
Responsible Party: | Rabin Medical Center ( Rabin Medical Center ) |
Study ID Numbers: | RMC085077CTIL, RMC local ID 5077 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00808990 |
Health Authority: | Israel: Ministry of Health |
Non Alcoholic Fatty Liver Disease Non Alcoholic SteatoHepatitis Small bowel bacterial overgrowth Probiotics Patients with Non Alcoholic Fatty Liver Disease |
Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Fatty Liver |