Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis

Alimentary Pharmacology and Therapeutics

Volumn 39, Issue 11, 2014, Pages 1276-1285

  Alisi, A ^a   Bedogni, G ^b   Baviera, G ^c   Giorgio, V ^a   Porro, E ^c   Paris, C ^c   Giammaria, P ^c   Reali, L ^c   Anania, F ^d   Nobili, V ^a  

^a BAMBINO GESÙ CHILDREN S HOSPITAL   (Italy)

^b Liver Research Center   (Italy)

^c Family Paediatrician   (Italy)

^d EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; GLUCAGON LIKE PEPTIDE 1; PLACEBO; TRIACYLGLYCEROL; VSL3;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY MASS; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; ECHOGRAPHY; FEMALE; HISTOPATHOLOGY; HOMOEOSTASIS MODEL ASSESSMENT INDEX; HUMAN; HUMAN CELL; HUMAN TISSUE; INSULIN RESISTANCE; INTESTINE FLORA; MALE; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NONALCOHOLIC FATTY LIVER; OBESITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; WEIGHT CHANGE;

ALANINE TRANSAMINASE; BIOPSY; BODY MASS INDEX; CHILD; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; FATTY LIVER; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; INSULIN RESISTANCE; MALE; OBESITY; PROBIOTICS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84900032263     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12758     Document Type: Article

References (49)

1. King B, Jiang Y, Su X, et al,. Weight control, endocrine hormones and cancer prevention. Exp Biol Med (Maywood) 2013; 238: 502-8.
2. Vazzana N, Santilli F, Sestili S, Cuccurullo C, Davi G,. Determinants of increased cardiovascular disease in obesity and metabolic syndrome. Curr Med Chem 2011; 18: 5267-80.
3. Nobili V, Svegliati-Baroni G, Alisi A, Miele L, Valenti L, Vajro P,. A 360-degree overview of paediatric NAFLD: recent insights. J Hepatol 2013; 58: 1218-29.
4. Alisi A, Feldstein AE, Villani A, Raponi M, Nobili V,. Pediatric nonalcoholic fatty liver disease: a multidisciplinary approach. Nat Rev Gastroenterol Hepatol 2012; 9: 152-61.
5. Alisi A, Cianfarani S, Manco M, Agostoni C, Nobili V,. Non-alcoholic fatty liver disease and metabolic syndrome in adolescents: pathogenetic role of genetic background and intrauterine environment. Ann Med 2012; 44: 29-40.
6. Oddy WH, Herbison CE, Jacoby P, et al,. The Western dietary pattern is prospectively associated with nonalcoholic fatty liver disease in adolescence. Am J Gastroenterol 2013; 108: 778-85.
7. Cordero P, Campion J, Milagro FI, Martinez JA,. Transcriptomic and epigenetic changes in early liver steatosis associated to obesity: effect of dietary methyl donor supplementation. Mol Genet Metab 2013; 110: 388-95.
8. Nobili V, Alisi A, Raponi M,. Pediatric non-alcoholic fatty liver disease: preventive and therapeutic value of lifestyle intervention. World J Gastroenterol 2009; 15: 6017-22.
9. Park JS, Seo JH, Youn HS,. Gut Microbiota and Clinical Disease: obesity and Nonalcoholic Fatty Liver Disease. Pediatr Gastroenterol Hepatol Nutr 2013; 16: 22-7.
10. Frasinariu OE, Ceccarelli S, Alisi A, Moraru E, Nobili V,. Gut-liver axis and fibrosis in nonalcoholic fatty liver disease: an input for novel therapies. Dig Liver Dis 2013; 45: 543-51.
11. Sabaté JM, Jouët P, Harnois F, et al,. High prevalence of small intestinal bacterial overgrowth in patients with morbid obesity: a contributor to severe hepatic steatosis. Obes Surg 2008; 18: 371-7.
12. Miele L, Valenza V, La Torre G, et al,. Increased intestinal permeability and tight junction alterations in nonalcoholic fatty liver disease. Hepatology 2009; 49: 1877-87.
13. Zhu L, Baker SS, Gill C, et al,. Characterization of gut microbiomes in nonalcoholic steatohepatitis (NASH) patients: a connection between endogenous alcohol and NASH. Hepatology 2013; 57: 601-9.
14. Bäckhed F, Ding H, Wang T, et al,. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci USA 2004; 101: 15718-23.
15. Cope K, Risby T, Diehl AM,. Increased gastrointestinal ethanol production in obese mice: implications for fatty liver disease pathogenesis. Gastroenterology 2000; 119: 1340-7.
16. Rivera CA, Adegboyega P, van Rooijen N, Tagalicud A, Allman M, Wallace M,. Toll-like receptor-4 signaling and Kupffer cells play pivotal roles in the pathogenesis of non-alcoholic steatohepatitis. J Hepatol 2007; 47: 571-9.
17. Li Z, Yang S, Lin H, et al,. Probiotics and antibodies to TNF inhibit inflammatory activity and improve nonalcoholic fatty liver disease. Hepatology 2003; 37: 343-50.
18. Mencarelli A, Cipriani S, Renga B, et al,. VSL#3 resets insulin signaling and protects against NASH and atherosclerosis in a model of genetic dyslipidemia and intestinal inflammation. PLoS ONE 2012; 7: e45425.
19. Mencarelli A, Distrutti E, Renga B, et al,. Probiotics modulate intestinal expression of nuclear receptor and provide counter-regulatory signals to inflammation-driven adipose tissue activation. PLoS ONE 2011; 6: e22978.
20. Velayudham A, Dolganiuc A, Ellis M, et al,. VSL#3 probiotic treatment attenuates fibrosis without changes in steatohepatitis in a diet-induced nonalcoholic steatohepatitis model in mice. Hepatology 2009; 49: 989-97.
21. Nobili V, Manco M, Devito R, et al,. Lifestyle intervention and antioxidant therapy in children with nonalcoholic fatty liver disease: a randomized, controlled trial. Hepatology 2008; 48: 119-28.
22. Nobili V, Alisi A, Della Corte C, et al,. Docosahexaenoic acid for the treatment of fatty liver: randomized controlled trial in children. Nutr Metab Cardiovasc Dis 2013; 23: 1066-70.
23. Hilton JF, Mehta CR,. Power and sample size calculations for exact conditional tests with ordered categorical data. Biometrics 1993; 49: 609-16.
24. Lohman TG, Roche AF, Martorell R,. Anthropometric standardization reference manual. Champaign, IL: Human Kinetics Books, 1988.
25. Cacciari E, Milani S, Balsamo A, et al,. Italian crosssectional growth charts for height, weight and BMI (2 to 20 yr). J Endocrinol Invest 2006; 29: 581-93.
26. Matthews DR, Hosker JP, Rudenski AS,. Homeostasis model assessment: insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985; 28: 412-9.
27. Kleiner DE, Brunt EM, Van Natta M, et al,. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology 2005; 41: 1313-21.
28. Agresti A,. Analysis of ordinal categorical data. Hoboken, NJ: Wiley, 2010.
29. Fitzmaurice GM, Laird NM, Ware JH,. Applied longitudinal analysis. Hoboken, N.J.: Wiley, 2011.
30. Rabe-Hesketh S, Skrondal A,. Multilevel and Longitudinal Modeling Using Stata, 3rd ed. College Station: Stata Press, 2012.
31. Williams R,. Fitting heterogeneous choice models with oglm. Stata Journal 2010; 10: 540-67.
32. Yadav H, Lee JH, Lloyd J, Walter P, Rane SG,. Beneficial metabolic effects of a probiotic via butyrate-induced GLP-1 hormone secretion. J Biol Chem 2013; 288: 25088-97.
33. Nobili V, Manco M, Ciampalini P, et al,. Metformin use in children with nonalcoholic fatty liver disease: an open label, 24-month, observational pilot study. Clin Ther 2008; 30: 1168-76.
34. Lavine JE, Schwimmer JB, Van Natta ML, et al,. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents: the TONIC randomized controlled trial. JAMA 2011; 305: 1659-68.
35. Nobili V, Bedogni G, Alisi A, et al,. Docosahexaenoic acid supplementation decreases liver fat content in children with non-alcoholic fatty liver disease: double-blind randomized controlled clinical trial. Arch Dis Child 2011; 96: 350-3.
36. Nobili V, Carpino G, Alisi A, et al,. Role of docosahexaenoic Acid treatment in improving liver histology in pediatric nonalcoholic Fatty liver disease. PLoS ONE 2014; 9: e88005.
37. Compare D, Coccoli P, Rocco A, et al,. Gut-liver axis: the impact of gut microbiota on non alcoholic fatty liver disease. Nutr Metab Cardiovasc Dis 2012; 22: 471-6.
38. Aron-Wisnewsky J, Gaborit JB, Dutour A, Clement K,. Gut microbiota and non-alcoholic fatty liver disease: new insights. Clin Microbiol Infect 2013; 19: 338-48.
39. Spencer MD, Hamp TJ, Reid RW, Fischer LM, Zeisel SH, Fodor AA,. Association between composition of the human gastrointestinal microbiome and development of fatty liver with choline deficiency. Gastroenterology 2011; 40: 976-86.
40. Brown K, DeCoffe D, Molcan E, Gibson DL,. Diet-induced dysbiosis of the intestinal microbiota and the effects on immunity and disease. Nutrients 2012; 4: 1095-119.
41. Mehal WZ,. The Gordian Knot of dysbiosis, obesity and NAFLD. Nat Rev Gastroenterol Hepatol 2013; 10: 637-44.
42. Iacono A, Raso GM, Canani RB, Calignano A, Meli R,. Probiotics as an emerging therapeutic strategy to treat NAFLD: focus on molecular and biochemical mechanisms. J Nutr Biochem 2011; 22: 699-711.
43. Wong VW, Won GL, Chim AM, et al,. Treatment of nonalcoholic steatohepatitis with probiotics. A proof-of-concept study. Ann. Hepatol 2013; 12: 256-62.
44. Vajro P, Mandato C, Licenziati MR, et al,. Effects of Lactobacillus rhamnosus strain GG in pediatric obesity-related liver disease. J Pediatr Gastroenterol Nutr 2011; 52: 740-3.
45. Loguercio C, Federico A, Tuccillo C, et al,. Beneficial effects of a probiotic VSL#3 on parameters of liver dysfunction in chronic liver diseases. J Clin Gastroenterol 2005; 39: 540-3.
46. Gallwitz B,. Emerging DPP-4 inhibitors: focus on linagliptin for type 2 diabetes. Diabetes Metab Syndr Obes 2013; 6: 1-9.
47. Lee J, Hong SW, Rhee EJ, Lee WY,. GLP-1 Receptor Agonist and Non- Alcoholic Fatty Liver Disease. Diabetes Metab J 2012; 36: 262-7.
48. Suzuki D, Toyoda M, Kimura M, et al,. Effects of liraglutide, a human glucagon-like peptide-1 analogue, on body weight, body fat area and body fat-related markers in patients with type 2 diabetes mellitus. Intern Med 2013; 52: 1029-34.
49. Kelly AS, Rudser KD, Nathan BM, et al,. The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial. JAMA Pediatr 2013; 167: 355-60.