Gut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease (NAFLD) but randomized controlled trials are lacking in children.
Dr Nobili and colleagues performed a double-blind randomized controlled trial of VSL#3 vs. placebo in obese children with biopsy-proven NAFLD.
Of 48 randomized children, 44 completed the study.
The team's 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.
|The probability of severe fatty liver after VSL#3 supplementation was 0%|
|Alimentary Pharmacology & Therapeutics|
At baseline, moderate and severe NAFLD were present in 64% and 36% of children in the placebo group, and in 55% and 45% of VSL#3 children.
The team found that the probability that children supplemented with VSL#3 had none, light, moderate or severe fatty liver 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.
The researchers detected no between-group differences in triglycerides, HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL#3 group.
Dr Nobili's team concludes, "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."