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The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

This study is not yet open for participant recruitment.
Verified October 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
weiss hemda, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00808990
First received: December 15, 2008
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Liver Disease
 Dietary Supplement: probiotics: BioFemale by SOLGAR Israel, SupHerb)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics and Non Alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test [ Time Frame: Recruitment period of 6 months and 6 months of treatment after each recruitment ] [ Designated as safety issue: No ]
  • Lactulose breath test [ Time Frame: Measurement at recruitment (0) and at the end of treatment period (6 mo) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment [ Time Frame: At recruitment to the study (0) and at the end of treatment (6 mo) ] [ Designated as safety issue: No ]
  • Fibromax test for the evaluation of NAFLD severity [ Time Frame: At the recruitment (0) and at the end of treatment (6 mo) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: OSA and NAFLD patients using CPAP
OSA and NAFLD patients using CPAP being followed for 6 months.
 Dietary Supplement: probiotics: BioFemale by SOLGAR Israel, SupHerb)

Use instructions: before breakfast 2 pills followed by cold drink or food.

Probiotics: Each pill contains 10x10^9 of the following bacteria:

Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus casei, Streptococcus thermophilus. All participants will receive either probiotics or placebo pills blindly for six months.

All participants will receive either probiotics or placebo pills blindly for six months.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808990

Contacts
Contact: Hemda Weiss, M.D. 97239372305 ext 2580 hemdaw@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel, 49100
Principal Investigator: Hemda Weiss, M.D.            
Sub-Investigator: Ziv Ben Ari, M.D.            
Sub-Investigator: Marius Braun, M.D.            
Sub-Investigator: Michal Cohen, M.D.            
Sub-Investigator: Ran Tur Kaspa, M.D.            
Sub-Investigator: Orit Pappo, M.D.            
Sub-Investigator: Jacklin Sulkes, Ph.D.            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Hemda Weiss, M.D. Rabin Medical Center
  More Information

Publications:

Responsible Party: weiss hemda, Dr., Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00808990     History of Changes
Other Study ID Numbers: RMC085077CTIL, RMC local ID 5077
Study First Received: December 15, 2008
Last Updated: October 29, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Non Alcoholic Fatty Liver Disease
Non Alcoholic SteatoHepatitis
Small bowel bacterial overgrowth
Probiotics
Patients with Non Alcoholic Fatty Liver Disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013