Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-15
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • probiotic (GKB7/placebo)

Treatment groups

110 Participants
are divided into 2 treatment groups