The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

NCT00808990 | Terminated Phase 1

• 2 other identifiers: RMC085077CTILRMC local ID 5077
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Disease

Keywords

Non Alcoholic Fatty Liver Disease; Non Alcoholic SteatoHepatitis; Small bowel bacterial overgrowth; Probiotics; Patients with Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Lactulose breath test

  Measurement at recruitment (0) and at the end of treatment period (6 mo)

Secondary Outcomes (2)

• 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)

• Fibromax test for the evaluation of NAFLD severity

  At the recruitment (0) and at the end of treatment (6 mo)

Study Arms (2)

OSA and NAFLD patients using CPAP

EXPERIMENTAL

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

Dietary Supplement: BioFemale

control

NO INTERVENTION

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

Interventions

BioFemale DIETARY_SUPPLEMENT

BioFemale 6 months.

OSA and NAFLD patients using CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Controls- healthy volunteers, male and female, above 18 years.
• NAFLD group - patients with histological proven NAFLD, male and female, above 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (8)

• 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.

  PMID: 12540784 BACKGROUND

• 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.

  PMID: 12190198 BACKGROUND

• 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.

  PMID: 17990113 BACKGROUND

• 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.

  PMID: 11316170 BACKGROUND

• 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.

  PMID: 9122234 BACKGROUND

• Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927.

  PMID: 11296694 BACKGROUND

• 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.

  PMID: 11156641 BACKGROUND

• 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.

  PMID: 18936646 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fatty Liver

Study Officials

• Hemda Weiss, M.D.

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

IL (1)