The Effect of Probiotics on Non Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT00808990|
Recruitment Status : Terminated (Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn)
First Posted : December 16, 2008
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease||Dietary Supplement: BioFemale||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Probiotics and Non Alcoholic Steatohepatitis (NASH)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
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.
- 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 ]
- Lactulose breath test [ Time Frame: Measurement at recruitment (0) and at the end of treatment period (6 mo) ]
- 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) ]
- Fibromax test for the evaluation of NAFLD severity [ Time Frame: At the recruitment (0) and at the end of treatment (6 mo) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808990
|Rabin Medical Center|
|Petach Tikva, Israel, 49100|
|Principal Investigator:||Hemda Weiss, M.D.||Rabin Medical Center|