title: Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis.
abstract: BACKGROUND
  Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children.
  
  
  OBJECTIVE
  To perform a double-blind RCT of VSL#3 vs. placebo in obese children with biopsy-proven NAFLD.
  
  
  METHODS
  Of 48 randomised children, 44 (22 VSL#3 and 22 placebo) completed the study. The main outcome was the change in fatty liver severity at 4 months as detected by ultrasonography. Secondary outcomes were the changes in triglycerides, insulin resistance as detected by the homoeostasis model assessment (HOMA), alanine transaminase (ALT), body mass index (BMI), glucagon-like peptide 1 (GLP-1) and activated GLP-1 (aGLP-1). Ordinal and linear models with cluster confidence intervals were used to evaluate the efficacy of VSL#3 vs. placebo at 4 months.
  
  
  RESULTS
  At baseline, moderate and severe NAFLD were present in 64% and 36% of PLA children and in 55% and 45% of VSL#3 children. The probability that children supplemented with VSL#3 had none, light, moderate or severe FL at the end of the study was 21%, 70%, 9% and 0% respectively with corresponding values of 0%, 7%, 76% and 17% for the placebo group (P < 0.001). No between-group differences were detected in triglycerides, HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL#3 group (P < 0.001 for all comparisons).
  
  
  CONCLUSIONS
  A 4-month supplement of VSL#3 significantly improves NAFLD in children. The VSL#3-dependent GLP-1 increase could be responsible for these beneficial effects. Trial identifier: NCT01650025 (www.clinicaltrial.gov).
authors.affiliation: Hepato-Metabolic Disease Unit and Liver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Alisi
authors.forename: G
authors.initials: G
authors.lastname: Bedogni
authors.forename: G
authors.initials: G
authors.lastname: Baviera
authors.forename: V
authors.initials: V
authors.lastname: Giorgio
authors.forename: E
authors.initials: E
authors.lastname: Porro
authors.forename: C
authors.initials: C
authors.lastname: Paris
authors.forename: P
authors.initials: P
authors.lastname: Giammaria
authors.forename: L
authors.initials: L
authors.lastname: Reali
authors.forename: F
authors.initials: F
authors.lastname: Anania
authors.forename: V
authors.initials: V
authors.lastname: Nobili
mesh_terms: D000410:Alanine Transaminase / Q000378:metabolism; D001706:Biopsy; D015992:Body Mass Index; D002648:Child; D019587:Dietary Supplements; D004311:Double-Blind Method; D005234:Fatty Liver / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000378:metabolism; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D065626:Non-alcoholic Fatty Liver Disease; D009765:Obesity / Q000150:complications*; D019936:Probiotics / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D052216:Glucagon-Like Peptide 1; D000410:Alanine Transaminase
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