This groundbreaking human study on the ASD microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning/deep learning platform development for ASD classification and prediction, and identification of diagnostic biomarkers. Upon completion, the investigators anticipate publishing at least 12 SCI papers and/or patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. The findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for ASD.
Children and adolescents aged 4 to 15 who are clinically diagnosed with ASD according to DSM-5 criteria and confirmed by the ADI-R/ADOS.
Caregivers cooperate with all the assessments and stool and blood collection.
A history of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression), neurological disorders, and substances use disorders.
Difficulty following instructions.
Consumption of antibiotics and yogurt or probiotic products two weeks prior to enrollment.
Parallel
probiotic (GKB7/placebo)
Other interventionThe objectives of this double-blind randomized placebo-controlled trial are to evaluate the tolerability, safety, and efficacy of the probiotic intervention with Clostridium butyricum GKB7 among 90 4-15-year-old children and adolescents with a clinical diagnosis of ASD according to the DSM-5
Clinical Global Impression
The CGI-S (Clinical Global Impression-Severity Scale) and CGI-I (-Improvement Scale) are single-item ratings of the clinician's assessment of the global severity of clinical symptoms. Severity and improvement are rated on a 7-point scale (from 1 = normal, not at all ill, to 7 = among the most extremely ill) and (from 1 = very much improved, to 7 = very much worse).
Social Responsiveness Scale (SRS)
The SRS is a 65-item questionnaire based on parent-reports on the child's social interactions with others (rating 0-3), consists of 5 subscales: social awareness, social cognition, social communication, social motivation, and autistic mannerisms
Self-administered questionnaires
The self-administered questionnaires include autistic symptoms (Autism Spectrum Quotient, AQ; Sensory Profile, SP), psychopathology (Child Behavior Checklist, CBCL; Swanson, Nolan, and Pelham, version IV scale, SNAP-IV), social functions/quality of life (Social Adjustment Inventory for Children and Adolescents, SAICA), and executive functions (Behavior Rating Inventories of Executive Function, BRIEF)
Neuropsychological functions: Continuous Performance Test(CPT)
The 4 dimensions of CCPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
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