The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Phase 1

Terminated

• Conditions: Liver Disease
• Interventions: Dietary Supplement: BioFemale

• Registration Number: NCT00808990
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Study Start: 2013-02
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA and NAFLD patients using CPAP	BioFemale	OSA and NAFLD patients using CPAP being followed for 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel