The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Clalit Health Services

Status and phase: Terminated; Phase 1

Conditions: Liver Disease

Treatments: Dietary Supplement: BioFemale

Study type: Interventional

Funder types: Other

Identifiers

NCT00808990

RMC085077CTIL

RMC local ID 5077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 2 patient groups

OSA and NAFLD patients using CPAP

Experimental group

Description:

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

Treatment:

Dietary Supplement: BioFemale

control

No Intervention group

Description:

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