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Tests a probiotic against placebo in children with autism spectrum disorder

Tests a probiotic, GKB7, against placebo in children with autism spectrum disorder.

Key facts

Who runs it
National Taiwan University Hospital
Where
Taipei, TaiwanSee the site
Trial code
Registry title
Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
Status
Recruiting
People taking part
110 people, planned
Started
1 May 2024
Expected to end
30 Apr 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • probiotic (GKB7/placebo)
Record updated
9 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 4 to 15 with autism spectrum disorder. It tests a probiotic (GKB7) against a placebo.

Age
4 to 15 years
Sex
All sexes can join.
Disease stage
Autism spectrum disorder diagnosed by DSM-5 criteria and confirmed by the ADI-R/ADOS.
Earlier treatment
Cannot have taken antibiotics, yogurt or probiotic products in the two weeks before enrollment.

Main reasons for not taking part

  • History of major psychiatric disorders such as schizophrenia, bipolar disorder or major depression
  • History of neurological disorders
  • History of substance use disorders
  • Difficulty following instructions
  • Antibiotics, yogurt or probiotics in the two weeks before enrollment

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Consumption of antibiotics and yogurt or probiotic products two weeks prior to enrollment
  • A history of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression), neurological disorders, and substances use disorders
  • Difficulty following instructions

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 15 years old?

Where in Taiwan

  • National Taiwan University HospitalTaipei, TaiwanContact: Susan Shur-Fen Gau, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • GKB7Treatment being tested

    Treatment: probiotic (GKB7/placebo)

  • PlaceboPlacebo, for comparison

    Treatment: probiotic (GKB7/placebo)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Precision Health in Autism: Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms
Plain-language title
Tests a probiotic against placebo in children with autism spectrum disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06677840, who can take part
Record updated
9 July 2026