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The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT00808990
Recruitment Status : Terminated (Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn)
First Posted : December 16, 2008
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
weiss hemda, 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.

Condition or disease Intervention/treatment Phase
Liver Disease Dietary Supplement: BioFemale Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Probiotics and Non Alcoholic Steatohepatitis (NASH)
Study Start Date : February 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: OSA and NAFLD patients using CPAP
OSA and NAFLD patients using CPAP being followed for 6 months.
Dietary Supplement: BioFemale
BioFemale 6 months.
No Intervention: control
OSA and NAFLD patients not using CPAP being followed for 6 months.



Primary Outcome Measures :
  1. 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 ]
  2. Lactulose breath test [ Time Frame: Measurement at recruitment (0) and at the end of treatment period (6 mo) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Fibromax test for the evaluation of NAFLD severity [ Time Frame: At the recruitment (0) and at the end of treatment (6 mo) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808990


Locations
Israel
Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Hemda Weiss, M.D. Rabin Medical Center

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
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by weiss hemda, 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:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases