Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
Recruiting
N/AInterventional Study
Autism Spectrum Disorder
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At a Glance
Age
4 – 15
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
National Taiwan University Hospital · Other
Who this trial is looking for
This trial is looking for children and adolescents aged 4 to 15 with autism spectrum disorder (ASD). Participants will take part in assessments and provide stool and blood samples to help evaluate a new probiotic treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 4 to 15.
I have been diagnosed with autism spectrum disorder (ASD).
My diagnosis is confirmed by the ADI-R or ADOS.
My caregivers will cooperate with all assessments.
I can provide stool and blood samples.
You may not be able to join if
I have a history of major psychiatric disorders.
I have a history of neurological disorders.
I have a substance use disorder.
I have difficulty following instructions.
I have consumed antibiotics in the last two weeks.
I have consumed yogurt or probiotic products in the last two weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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-…
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.
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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 disor…
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.
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