Evaluating Postbiotic Supplement Effects on Gut Health and Behavior in Children Aged 3-8 with Autism Spectrum Disorder

What this Trial Is About

Researchers are investigating the role of gut microbiota in Autism Spectrum Disorders ASD and the potential benefits of postbiotic-based dietary supplements in children aged 3 to 8 years. ASD is a neurobiological condition with complex causes, often accompanied by gastrointestinal symptoms that may influence the severity of behavioral symptoms. This study aims to explore non-drug treatments to improve gastrointestinal and behavioral symptoms in children with ASD, enhancing clinical management strategies. The study involves three groups of children aged 3 to 8 years those with ASD and gastrointestinal symptoms, those with ASD without gastrointestinal symptoms, and typically developing children without gastrointestinal issues. Participants in the first two groups will receive a postbiotic dietary supplement called PostbiotiX Comfort for one month, while the third group will not receive any treatment. PostbiotiX Comfort contains molecules from Lactobacillus paracasei fermentation that may support intestinal health and barrier integrity without live bacteria risks. Participants will provide stool samples for analysis of their gut bacteria, intestinal permeability, and metabolomic profiles before and after treatment. Researchers will evaluate changes in gastrointestinal symptoms, behavioral regulation, sleep, sensory profile, and the relationship between gut profiles and clinical outcomes over a 24-month period. The study includes assessments by neurologists and neuropsychologists, and all participants will be monitored for safety and treatment effects throughout the study.

Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders