Efficacy of Lactobacillus Reuteri in Managing Social Deficits in Children With Autistic Spectrum Disorder: a Randomized Clinical Trial With Evaluation of Gut Microbiota and Metabolomics Profiles

Autism Spectrum Disorder (ASD) is a condition that includes social deficits, repetitive behaviors and language difficulties; its prevalence continues to increase worldwide, however, there are no medication for the core symptoms of this disorder. In addition to these core symptoms, children with ASD are 3.5 times more likely to suffer from gastrointestinal issues than children without developmental disorders. Moreover, GI problems have been associated with changes in the microbial communities inhabiting the gut of ASD individuals.

Studies in animal models have suggested that the gut microbes can modulate central nervous system-driven behaviors.

In 2019, a research group (Buffington et al.) found that a specific strain (L. Reuteri PTA) rescues the deficit in social interaction-induced VTA plasticity in ASD mouse, enhancing the salience and rewarding value of social stimuli.

These data support the idea that microbial therapies could ameliorate specific endophenotypes associates with ASD.

Aim of the study The aim of this pilot study is to determine the possible effects of supplementation with a specific probiotic strain (L. Reuteri ATCC PTA 6475) in ASD children on the core deficits of the disorder, the social behavior. A secondary aim is to evaluate the effects of probiotic supplementation on specific GI symptoms, and repetitive, dysfunctional behaviors, widely described in ASD children. Finally, the investigators will evaluate gut microbiota (fecal and salivary samples) and metabolomics (urinary samples) profiles differences before and after the supplementation.