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

A. Alisi, G. Bedogni, G. Baviera, V. Giorgio, E. Porro, C. Paris, P. Giammaria, L. Reali, F. Anania, V. Nobili

Research output: Contribution to journalArticlepeer-review


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)

Original languageEnglish
Pages (from-to)1276-1285
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Issue number11
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Pharmacology (medical)

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