Exploring the gut-brain connection in autism with probiotics and AI
Official title: Precision Health in Autism: Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
Run by National Taiwan University Hospital · NCT06677840 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 15 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06677840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 4 to 15 who have a clinical diagnosis of ASD.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sensory Integration and Deep Pressure Therapy for Motor Coordination in Children with ASD
This study tests whether combining Sensory Integration Therapy with Deep Pressure Therapy can improve motor coordination and reduce repetitive behaviors in children aged 4–10 with autism.
-
Pupillometer screen to help identify autism in kids aged 2–4 during routine visits
A handheld pupillometer test is being tried to see if it can help identify autism in young children during regular pediatric visits.
-
Leopard: using multi-omics to boost genetic diagnosis for neurodevelopmental disorders
This study tests a multi-omics approach to find genetic explanations for neurodevelopmental disorders in people with moderate-to-severe intellectual disability.
-
Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
This study tests a wearable heart rate variability biofeedback tool to see if it helps reduce anxiety in autistic teens.
-
Structured Sensory-Based Occupational Therapy for Children with Autism
This study tests a 12-week, 40-minute sensory-based occupational therapy program twice a week to see if it improves daily skills, sensory processing, movement, and eating in children aged 3-9 with autism.
-
Exergaming and Aerobic Exercise for Kids with Autism
This study tests whether adding exergames or aerobic exercise to a standard program helps improve sleep, movement skills, thinking skills, and brain activity in children with autism.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.