Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder

This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.

Inclusion Criteria: * Boys or girls aged between 4 to 12 years at screening. * ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool. * Parents/caregivers/legal guardians are ≥18 years. * Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period. * Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator. * Parents/caregivers/legal guardians willing and able to give informed consent for their and their child's participation in the study. Exclusion Criteria: * Neurological syndromes that could explain autism disorders. * Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted * Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement. * Allergy or intolerance to one of the excipients of the probiotic product. * Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1). * Children with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1). * Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1). * Participation in other interventional clinical study.