Liver Disease
Conditions
Keywords
Non Alcoholic Fatty Liver Disease, Non Alcoholic SteatoHepatitis, Small bowel bacterial overgrowth, Probiotics, Patients with Non Alcoholic Fatty Liver Disease
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, 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.
Interventions
DIETARY_SUPPLEMENTBioFemale
BioFemale 6 months.
Sponsors
Rabin Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Controls- healthy volunteers, male and female, above 18 years. * NAFLD group - patients with histological proven NAFLD, male and female, above 18 years.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactulose breath test | Measurement at recruitment (0) and at the end of treatment period (6 mo) |
| SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test | Recruitment period of 6 months and 6 months of treatment after each recruitment |
Secondary
| Measure | Time frame |
|---|---|
| FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment | At recruitment to the study (0) and at the end of treatment (6 mo) |
| Fibromax test for the evaluation of NAFLD severity | At the recruitment (0) and at the end of treatment (6 mo) |
Countries
Israel
Outcome results
None listed