NCT06677840 Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
| NCT ID | NCT06677840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 microbiome and metabolomic biomarkers and endophenotypes of ASD, and to establish Gut-Brain-Behavioral Axes in ASD.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06677840 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 15 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06677840 currently recruiting?
Yes, NCT06677840 is actively recruiting participants. Contact the research team at gaushufe@ntu.edu.tw for enrollment information.
Where is the NCT06677840 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06677840 clinical trial?
NCT06677840 is sponsored by National Taiwan University Hospital. The trial plans to enroll 110 participants.