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Study identifier: NCT06677840 Synced from ClinicalTrials.gov · July 28, 2026
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Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms

Condition: Autism Spectrum Disorder  ·  Sponsor: National Taiwan University Hospital

PhaseNA
Planned participants110
Who can joinAll sexes, 4 Years to 15 Years
Healthy volunteersNo

About this study

With an increased prevalence of autism spectrum disorder (ASD) worldwide and in Taiwan, ASD demands urgent attention due to its lasting impact, unclear causes, and limited diagnostic and treatment options. Recent studies highlight disruptions in the gut-brain axis, particularly in ASD. Building on PI Gau's prior research on altered gut microbiota in autism spectrum disorder (ASD), this proposed 4-year study aims to develop evidence-based probiotic intervention (GKB7) and treatment biomarkers for behavioral interventions (Naturalistic Developmental Behavioral Interventions, NDBI, and Program for the Education and Enrichment of Relational Skills, PEERS®) through comprehensive assessments. The ultimate goal is to establish probiotic treatments and diagnostic/treatment biomarkers for ASD utilizing a deep-learning multimodal auxiliary platform. Specific Aims: S.I To conduct a randomized, double-blind, placebo-controlled trial to assess the treatment effects of Clostridium butyricum GKB7 on ASD. S.II To investigate the effect of NDBI intervention trials using metagenomics as the outcome measure. S.III To evaluate the effect of PEERS® interventional trials with metagenomics as the outcome measure. S.IV To develop an artificial intelligence (machine/deep learning) multimodal auxiliary prediction platform that integrates environmental, behavioral/clinical, neurocognitive/imaging, and metagenomic data for ASD diagnosis, subtyping, and impairment prediction. S.V To identify microb…

This description comes directly from the study's public registry record.

Talk to the study team

Susan Shur-Fen Gau, MD, PhD  ·  +886-2-23123456  ·  gaushufe@ntu.edu.tw

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Locations (1)

National Taiwan University HospitalTaipei, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT06677840