The Effect of Probiotics on Non Alcoholic Fatty Liver Disease
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Probiotics and Non Alcoholic Steatohepatitis (NASH)|
- SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test [ Time Frame: Recruitment period of 6 months and 6 months of treatment after each recruitment ] [ Designated as safety issue: No ]
- Lactulose breath test [ Time Frame: Measurement at recruitment (0) and at the end of treatment period (6 mo) ] [ Designated as safety issue: No ]
- FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment [ Time Frame: At recruitment to the study (0) and at the end of treatment (6 mo) ] [ Designated as safety issue: No ]
- Fibromax test for the evaluation of NAFLD severity [ Time Frame: At the recruitment (0) and at the end of treatment (6 mo) ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Study Completion Date:||September 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: OSA and NAFLD patients using CPAP
OSA and NAFLD patients using CPAP being followed for 6 months.
Dietary Supplement: BioFemale
BioFemale 6 months.
No Intervention: control
OSA and NAFLD patients not using CPAP being followed for 6 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808990
|Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Hemda Weiss, M.D.||Rabin Medical Center|