The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Probiotics and Non Alcoholic Steatohepatitis (NASH)

Conditions
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Liver Disease

Intervention / Treatment
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* Dietary Supplement: BioFemale


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA and NAFLD patients using CPAP<br>OSA and NAFLD patients using CPAP being followed for 6 months. | Dietary Supplement: BioFemale<br>* BioFemale 6 months.<br>|
| No Intervention: control<br>OSA and NAFLD patients not using CPAP being followed for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Lactulose breath test |  | Measurement at recruitment (0) and at the end of treatment period (6 mo) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Alcoholic Fatty Liver Disease, Non Alcoholic SteatoHepatitis, Small bowel bacterial overgrowth, Probiotics, Patients with Non Alcoholic Fatty Liver Disease