Exploring the gut-brain connection in autism with probiotics and AI
Precision Health in Autism: Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
This study is testing if a specific probiotic can help improve symptoms of autism while also looking at how behavioral therapies and new technology can better support people with autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06677840 on ClinicalTrials.gov |
What this trial studies
This innovative study investigates the relationship between gut microbiota and autism spectrum disorder (ASD) through a randomized, double-blind, placebo-controlled trial using the probiotic Clostridium butyricum GKB7. It aims to assess the treatment effects of probiotics on ASD symptoms while also exploring the efficacy of behavioral interventions like Naturalistic Developmental Behavioral Interventions and PEERS®. Additionally, the study will develop an artificial intelligence platform to integrate various data types for improved diagnosis and treatment of ASD. The findings are expected to enhance understanding of ASD and contribute to precision medicine approaches.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 4 to 15 who have a clinical diagnosis of ASD.
Not a fit: Patients with major psychiatric or neurological disorders, or those who have recently consumed antibiotics or probiotics, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for children with autism spectrum disorder.
How similar studies have performed: While there have been studies exploring the gut-brain axis in ASD, this approach combining probiotics and AI for diagnosis and treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Susan Shur-Fen Gau, MD, PhD
- Email: gaushufe@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.