AUTHOR=Derosa Giuseppe , Guasti Luigina , D’Angelo Angela , Martinotti Chiara , Valentino Maria Chiara , Di Matteo Sergio , Bruno Giacomo M. , Maresca Andrea M. , Gaudio Giovanni V. , Maffioli Pamela 

TITLE=Probiotic Therapy With VSL#3® in Patients With NAFLD: A Randomized Clinical Trial

JOURNAL=Frontiers in Nutrition

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.846873

DOI=10.3389/fnut.2022.846873

ISSN=2296-861X

ABSTRACT=<sec><title>Aim</title><p>To evaluate if VSL#3<sup>®</sup> [a high-concentration multi-strain probiotic mix containing one strain of <italic>Streptococcus thermophilus</italic> BT01, three strains of <italic>Bifidobacteria</italic> (<italic>B. breve</italic> BB02; <italic>B. animalis</italic> subspecies [subsp.] <italic>lactis</italic> BL03, previously identified as <italic>B. longum</italic> BL03; and <italic>B. animalis</italic> subsp. <italic>lactis</italic> BI04, previously identified as <italic>B. infantis</italic> BI04), and four strains of <italic>Lactobacilli</italic> (<italic>L. acidophilus</italic> BA05, <italic>L. plantarum</italic> BP06, <italic>L. paracasei</italic> BP07, and <italic>L. helveticus</italic> BD08, previously identified as <italic>L. delbrueckii</italic> subsp. <italic>bulgaricus</italic> BD08)] therapy could improve hepatic parameters.</p></sec><sec><title>Methods</title><p>We enrolled 60 Caucasian patients aged ≥ 18 years of either sex with the diagnosis of non-alcoholic fatty liver disease (NAFLD), according to practice guidance, in a double-blind, placebo-controlled study. Patients were randomized to take placebo or VSL#3<sup>®</sup>, 2 sachets/day in the morning for 3 months. VSL#3<sup>®</sup> and placebo were self-administered.</p></sec><sec><title>Results</title><p>We did not observe any change in body mass index (BMI), circumferences, fasting plasma glucose (FPG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and adiponectin (ADN) with neither treatment. A statistically significant triglycerides (Tg) decrease (<italic>p</italic> &lt; 0.05 vs. baseline, and <italic>p</italic> &lt; 0.05 vs. placebo, respectively) and high-sensitivity C-reactive protein (Hs-CRP) decrease (<italic>p</italic> &lt; 0.05 vs. baseline) was observed in the group of patients being treated with VSL#3<sup>®</sup> compared with placebo. Transaminases and gamma-glutamyltransferase (γ-GT) were significantly reduced in VSL#3<sup>®</sup> group (<italic>p</italic> &lt; 0.05 vs. baseline and placebo, respectively) compared with the placebo group. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio and hepatic steatosis index (HSI) were significantly lower than the VSL#3<sup>®</sup> group (<italic>p</italic> &lt; 0.05 vs. baseline and placebo, respectively) compared with the placebo group. All patients reported an improvement or the disappearance of hepatic steatosis.</p></sec><sec><title>Conclusion</title><p>Probiotic therapy with VSL#3<sup>®</sup> ameliorates hepatic parameters and echography grading, while reducing Tg and the inflammatory status, without any difference between men and women.</p></sec>