search
Back to results

The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Primary Purpose

Liver Disease

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
BioFemale
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring Non Alcoholic Fatty Liver Disease, Non Alcoholic SteatoHepatitis, Small bowel bacterial overgrowth, Probiotics, Patients with Non Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OSA and NAFLD patients using CPAP

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test
Lactulose breath test

Secondary Outcome Measures

FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment
Fibromax test for the evaluation of NAFLD severity

Full Information

First Posted
December 15, 2008
Last Updated
April 7, 2016
Sponsor
Rabin Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00808990
Brief Title
The Effect of Probiotics on Non Alcoholic Fatty Liver Disease
Official Title
Probiotics and Non Alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Non Alcoholic Fatty Liver Disease, Non Alcoholic SteatoHepatitis, Small bowel bacterial overgrowth, Probiotics, Patients with Non Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSA and NAFLD patients using CPAP
Arm Type
Experimental
Arm Description
OSA and NAFLD patients using CPAP being followed for 6 months.
Arm Title
control
Arm Type
No Intervention
Arm Description
OSA and NAFLD patients not using CPAP being followed for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
BioFemale
Intervention Description
BioFemale 6 months.
Primary Outcome Measure Information:
Title
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
Title
Lactulose breath test
Time Frame
Measurement at recruitment (0) and at the end of treatment period (6 mo)
Secondary Outcome Measure Information:
Title
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)
Title
Fibromax test for the evaluation of NAFLD severity
Time Frame
At the recruitment (0) and at the end of treatment (6 mo)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hemda Weiss, M.D.
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
12540784
Citation
Li Z, Yang S, Lin H, Huang J, Watkins PA, Moser AB, Desimone C, Song XY, Diehl AM. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology. 2003 Feb;37(2):343-50. doi: 10.1053/jhep.2003.50048.
Results Reference
background
PubMed Identifier
12190198
Citation
Loguercio C, De Simone T, Federico A, Terracciano F, Tuccillo C, Di Chicco M, Carteni M. Gut-liver axis: a new point of attack to treat chronic liver damage? Am J Gastroenterol. 2002 Aug;97(8):2144-6. doi: 10.1111/j.1572-0241.2002.05942.x. No abstract available.
Results Reference
background
PubMed Identifier
17990113
Citation
Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.
Results Reference
background
PubMed Identifier
11316170
Citation
Nair S, Cope K, Risby TH, Diehl AM. Obesity and female gender increase breath ethanol concentration: potential implications for the pathogenesis of nonalcoholic steatohepatitis. Am J Gastroenterol. 2001 Apr;96(4):1200-4. doi: 10.1111/j.1572-0241.2001.03702.x. Erratum In: Am J Gastroenterol 2001 Sep;96(9):2809. Terence RH [corrected to Risby TH].
Results Reference
background
PubMed Identifier
9122234
Citation
Yang SQ, Lin HZ, Lane MD, Clemens M, Diehl AM. Obesity increases sensitivity to endotoxin liver injury: implications for the pathogenesis of steatohepatitis. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2557-62. doi: 10.1073/pnas.94.6.2557.
Results Reference
background
PubMed Identifier
11296694
Citation
Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927.
Results Reference
background
PubMed Identifier
11156641
Citation
Wigg AJ, Roberts-Thomson IC, Dymock RB, McCarthy PJ, Grose RH, Cummins AG. The role of small intestinal bacterial overgrowth, intestinal permeability, endotoxaemia, and tumour necrosis factor alpha in the pathogenesis of non-alcoholic steatohepatitis. Gut. 2001 Feb;48(2):206-11. doi: 10.1136/gut.48.2.206.
Results Reference
background
PubMed Identifier
18936646
Citation
Solga SF, Buckley G, Clark JM, Horska A, Diehl AM. The effect of a probiotic on hepatic steatosis. J Clin Gastroenterol. 2008 Nov-Dec;42(10):1117-9. doi: 10.1097/MCG.0b013e31816d920c. No abstract available.
Results Reference
background

Learn more about this trial

The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

We'll reach out to this number within 24 hrs