Psychobiotics in pediatric autism spectrum disorder: A systematic review of efficacy, mechanisms, and clinical translation

Table 1 Population, intervention, comparison, and outcome framework for the systematic review on psychobiotics in children with autism spectrum disorder

Component	Description
Population	Children and adolescents aged ≤ 18 years with a clinical diagnosis of ASD based on recognized diagnostic criteria (e.g., DSM or ICD) or validated diagnostic tools
Intervention	Psychobiotic interventions intended to modulate the gut-brain axis, including probiotics, prebiotics, synbiotics, and postbiotics, are administered as supplements, fortified foods, or dietary formulations
Comparator	Placebo, standard/usual care, dietary control, or no intervention
Outcomes	Primary outcomes: Changes in core ASD symptoms measured by validated behavioral scales (e.g., ADOS, CARS, SRS). Secondary outcomes: Gastrointestinal symptoms, quality of life, gut microbiota composition or diversity, immune or metabolic biomarkers, and safety outcomes, including adverse events
Study design	Randomized controlled trials, non-randomized controlled studies, cohort studies, and pre-post intervention studies evaluating psychobiotic interventions in pediatric ASD populations

DSM: Diagnostic and Statistical Manual of Mental Disorders; ICD: International Statistical Classification of Diseases; ADOS: Autism Diagnostic Observation Schedule; CARS: Childhood Autism Rating Scale; SRS: Social Responsiveness Scale.