title: Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study.
abstract: BACKGROUND
  Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the world. Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora, which can influence the gut-liver axis.
  
  
  OBJECTIVE
  The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis, liver enzymes, and inflammatory markers in patients with NAFLD.
  
  
  METHODS
  In a randomized, double-blind, placebo-controlled clinical trial conducted as a pilot study, 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups were advised to follow an energy-balanced diet and physical activity recommendations.
  
  
  RESULTS
  At the end of the study, the alanine aminotransferase (ALT) concentration decreased in both groups; this reduction was significantly greater in the synbiotic group. At the end of the study, the following significant differences [means (95% CIs)] were seen between the synbiotic and placebo groups, respectively: ALT [-25.1 (-26.2, -24) compared with -7.29 (-9.5, -5.1) IU/L; P < 0.001], aspartate aminotransferase [-31.33 (-32.1, -30.5) compared with -7.94 (-11.1, -4.8) IU/L; P < 0.001], γ-glutamyltransferase [-15.08 (-15.5, -14.7) compared with -5.21 (-6.6, -3.9) IU/L; P < 0.001], high-sensitivity C-reactive protein [-2.3 (-3, -1.5) compared with -1.04 (-1.5, -0.6) mmol/L; P < 0.05], tumor necrosis factor-α [-1.4 (-1.7, -1.1) compared with -0.59 (-0.8, -0.3) mmol/L; P < 0.001], total nuclear factor κ-B p65 [-0.016 (-0.022, -0.011) compared with 0.001 (-0.004, -0.007) mmol/L; P < 0.001], and fibrosis score as determined by transient elastography [- 2.98 (-3.6, -2.37) compared with -0.77 (-1.32, -0.22) kPa; P < 0.001].
  
  
  CONCLUSIONS
  Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD, at least partially through attenuation of inflammatory markers in the body. Whether these effects will be sustained with longer treatment durations remains to be determined.
authors.affiliation: Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran (TE and AH); the Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran (TE, HP, MS, and RM); and the Gastroenterology and Liver Disease Research Center, Firoozgar Hospital, Tehran University of Medical Sciences, Tehran, Iran (FZ).
authors.forename: Tannaz
authors.initials: T
authors.lastname: Eslamparast
authors.forename: Hossein
authors.initials: H
authors.lastname: Poustchi
authors.forename: Farhad
authors.initials: F
authors.lastname: Zamani
authors.forename: Maryam
authors.initials: M
authors.lastname: Sharafkhah
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
authors.forename: Azita
authors.initials: A
authors.lastname: Hekmatdoost
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D003131:Combined Modality Therapy; D004038:Diet, Reducing; D004311:Double-Blind Method; D005234:Fatty Liver / Q000150:complications / Q000178:diet therapy* / Q000276:immunology / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D057194:Intention to Treat Analysis; D008019:Life Style; D008103:Liver Cirrhosis / Q000209:etiology / Q000517:prevention & control; D059012:Lost to Follow-Up; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D065626:Non-alcoholic Fatty Liver Disease; D050177:Overweight / Q000150:complications / Q000178:diet therapy / Q000628:therapy*; D010352:Patient Dropouts; D010353:Patient Education as Topic; D010865:Pilot Projects; D058616:Synbiotics
chemical_list: D015415:Biomarkers; D018836:Inflammation Mediators