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

ABSTRACT:

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 evalu

SUBMITTER: Alisi A 

PROVIDER: S-EPMC4046270 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature