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Randomised clinical trial: the beneficial effects of VSL #3 in obese children with non‐alcoholic steatohepatitis
Author(s) -
Alisi A.,
Bedogni G.,
Baviera G.,
Giorgio V.,
Porro E.,
Paris C.,
Giammaria P.,
Reali L.,
Anania F.,
Nobili V.
Publication year - 2014
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12758
Subject(s) - medicine , placebo , fatty liver , gastroenterology , steatohepatitis , insulin resistance , alanine transaminase , body mass index , confidence interval , randomized controlled trial , aspartate transaminase , obesity , disease , pathology , biochemistry , chemistry , alkaline phosphatase , enzyme , alternative medicine
Summary 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 a GLP 1 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 )