The Effect of Probiotics on Non Alcoholic Fatty Liver Disease - Full Text View

Sponsored by:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00808990

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)

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Probiotics and Non Alcoholic Steatohepatitis (NASH)

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 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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
Petach Tikva, Israel, 49100

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Hemda Weiss, M.D.

Rabin Medical Center

More Information

Publications:

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.

Loguercio C, De Simone T, Federico A, Terracciano F, Tuccillo C, Di Chicco M, Cartenì M. Gut-liver axis: a new point of attack to treat chronic liver damage? Am J Gastroenterol. 2002 Aug;97(8):2144-6. No abstract available.

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. Review.

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. Erratum in: Am J Gastroenterol 2001 Sep;96(9):2809. Terence RH [corrected to Risby TH].

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.

Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. Review.

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.

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. No abstract available.

Responsible Party:	Rabin Medical Center ( Rabin Medical Center )
Study ID Numbers:	RMC085077CTIL, RMC local ID 5077
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808990 History of Changes
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

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on May 07, 2009