Status:
TERMINATED
The Effect of Probiotics on Non Alcoholic Fatty Liver Disease
Lead Sponsor:
Rabin Medical Center
Conditions:
Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, steatohepa...
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 trea...
Eligibility Criteria
Inclusion
- Controls- healthy volunteers, male and female, above 18 years.
- NAFLD group - patients with histological proven NAFLD, male and female, above 18 years.
Exclusion
- Controls
- those who will be found to have fatty liver in abdominal ultra sound
- any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
- any participant who had lost more than 10% of baseline body weight during the study period.
- NAFLD group
- those who will be found to have any concomitant liver disease (i.e., HBV/HCV/HIV/EBV/CMV infection
- autoimmune hepatitis
- metabolic liver disease: Wilson's disease, cholestatic liver disease: PBC/PSC, etc.)
- any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
- any participant who had lost more than 10% of baseline body weight during the study period
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00808990
Start Date
February 1 2013
End Date
September 1 2015
Last Update
April 8 2016
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel, 49100