RecruitingNot ApplicableNCT06677840

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

Precision Health in Autism: Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms


Sponsor

National Taiwan University Hospital

Enrollment

110 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 4 YearsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying probiotic (GKB7/placebo) for people with autism spectrum disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 4 Years to 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERprobiotic (GKB7/placebo)

The 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


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06677840


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