Precision Microbial Intervention Improves Social Behavior but Not Autism Severity: A Pilot Double-Blind Randomized Placebo-Controlled Trial

Authors

• Luigi Mazzone
• Sean W Dooling
• Elisabetta Volpe
• Mirko Uljarević
• Jillian L Waters
• Andrea Sabatini
• Lucrezia Arturi
• Roberta Abate
• Assia Riccioni
• Martina Siracusano
• Marcela Pereira
• Lars Engstrand
• Fernanda Cristofori
• Domenico Adduce
• Ruggiero Francavilla
• Mauro Costa-Mattioli
• Antonio Y Hardan

Language

English

Publication Date

1-10-2024

Journal

Cell Host & Microbe

DOI

10.1016/j.chom.2023.11.021

PMID

38113884

Abstract

Autism spectrum disorder (ASD) is characterized by the presence of restricted/repetitive behaviors and social communication deficits. Because effective treatments for ASD remain elusive, novel therapeutic strategies are necessary. Preclinical studies show that L. reuteri selectively reversed social deficits in several models for ASD. Here, in a double-blind, randomized, placebo-controlled trial, we tested the effect of L. reuteri (a product containing a combination of strains ATCC-PTA-6475 and DSM-17938) in children with ASD. The treatment does not alter overall autism severity, restricted/repetitive behaviors, the microbiome composition, or the immune profile. However, L. reuteri combination yields significant improvements in social functioning that generalized across different measures. Interestingly, ATCC-PTA-6475, but not the parental strain of DSM-17938, reverses the social deficits in a preclinical mouse model for ASD. Collectively, our findings show that L. reuteri enhances social behavior in children with ASD, thereby warranting larger trials in which strain-specific effects should also be investigated.

Keywords

Child, Mice, Animals, Humans, Autistic Disorder, Autism Spectrum Disorder, Social Behavior, Treatment Outcome, Double-Blind Method, autism spectrum disorder, clinical trial, gut-microbiome-brain axis, probiotic, social behavior

Comments

Trial registration: ClinicalTrials.gov NCT04293783.

Published Open-Access

yes

Recommended Citation

Mazzone, Luigi; Dooling, Sean W; Volpe, Elisabetta; et al., "Precision Microbial Intervention Improves Social Behavior but Not Autism Severity: A Pilot Double-Blind Randomized Placebo-Controlled Trial" (2024). Faculty, Staff and Students Publications. 7272.
https://digitalcommons.library.tmc.edu/baylor_docs/7272