The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Liver Disease Clinical Trial

Official title:

Probiotics and Non Alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00808990
• Other study ID #: RMC085077CTIL
• Secondary ID: RMC local ID 507
• Status: Terminated
• Phase: Phase 1
• First received: December 15, 2008
• Last updated: April 7, 2016
• Start date: February 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Dietary Supplement:
• BioFemale
BioFemale 6 months.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIBO in NASH patients in both treated groups (probiotics treated versus placebo treated) will be evaluated by lactulose breath test		Recruitment period of 6 months and 6 months of treatment after each recruitment	No
Primary	Lactulose breath test		Measurement at recruitment (0) and at the end of treatment period (6 mo)	No
Secondary	FIBROMAX tests will assess severity of NAFLD in patients' group prior to treatment and post treatment		At recruitment to the study (0) and at the end of treatment (6 mo)	No
Secondary	Fibromax test for the evaluation of NAFLD severity		At the recruitment (0) and at the end of treatment (6 mo)	No