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

Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.


Background: Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children.

Aim: 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).

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Alanine Transaminase / metabolism
  • Biopsy
  • Body Mass Index
  • Child
  • Dietary Supplements*
  • Double-Blind Method
  • Fatty Liver / diagnostic imaging
  • Fatty Liver / physiopathology
  • Fatty Liver / therapy*
  • Female
  • Glucagon-Like Peptide 1 / metabolism
  • Humans
  • Insulin Resistance
  • Male
  • Non-alcoholic Fatty Liver Disease
  • Obesity / complications*
  • Probiotics / therapeutic use*
  • Severity of Illness Index
  • Treatment Outcome
  • Ultrasonography


  • Glucagon-Like Peptide 1
  • Alanine Transaminase

Associated data

  • ClinicalTrials.gov/NCT01650025