Randomised clinical trial: the beneficial effects of VSL#3 in obese children with non‐alcoholic steatohepatitis. Issue 11 (16th April 2014)

• Record Type: Journal Article
• Authors: Alisi, A.; Bedogni, G.; Baviera, G.; Giorgio, V.; Porro, E.; Paris, C.; Giammaria, P.; Reali, L.; Anania, F.; Nobili, V.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 39:Issue 11(2014)
• Page Start: 1276
• Page End: 1285
• Publication Date: 2014-04-16
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12758
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12758-abs-0001"> <title>Summary</title> <sec id="apt12758-sec-0001" sec-type="section"> <title>Background</title> <p>Gut microbiota modifiers may have beneficial effects of non‐alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children.</p> </sec> <sec id="apt12758-sec-0002" sec-type="section"> <title>Aim</title> <p>To perform a double‐blind RCT of VSL#3 vs. placebo in obese children with biopsy‐proven NAFLD.</p> </sec> <sec id="apt12758-sec-0003" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="apt12758-sec-0004" sec-type="section"> <title>Results</title> <p>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 (<italic>P </italic><<italic> </italic>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 (<italic>P </italic><<italic> </italic>0.001 for all comparisons).</p> </sec> <sec id="apt12758-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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 (<ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrial.gov" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">www.clinicaltrial.gov</ext-link>)</p> </sec> </abstract>