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| ID | Type | Description | Link |
|---|---|---|---|
| RMC local ID 5077 |
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Time table was unfulfilled due to incompetent research coordinator. Inaccurate results and No conclusions can be withdrawn
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA and NAFLD patients using CPAP | Experimental | OSA and NAFLD patients using CPAP being followed for 6 months. |
|
| control | No Intervention | OSA and NAFLD patients not using CPAP being followed for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFemale | Dietary Supplement | BioFemale 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Controls
NAFLD group
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| Name | Affiliation | Role |
|---|---|---|
| Hemda Weiss, M.D. | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12540784 | Background | 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. | |
| 12190198 | 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. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005234 | Fatty Liver |
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| 17990113 | 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. |
| 11316170 | 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. |
| 9122234 | 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. |
| 11296694 | Background | Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927. |
| 11156641 | 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. |
| 18936646 | 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. |