The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

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.

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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.

Conditions

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Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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OSA and NAFLD patients using CPAP

OSA and NAFLD patients using CPAP being followed for 6 months.

Group Type EXPERIMENTAL

BioFemale

Intervention Type DIETARY_SUPPLEMENT

BioFemale 6 months.

control

OSA and NAFLD patients not using CPAP being followed for 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BioFemale

BioFemale 6 months.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes