Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms

NCT06677840 | Recruiting DMC

• 1 other identifier: 202404049RIPA
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This groundbreaking human study on the ASD microbiome includes probiotic clinical trials, investigation of treatment biomarkers, machine learning/deep learning platform development for ASD classification and prediction, and identification of diagnostic biomarkers. Upon completion, the investigators anticipate publishing at least 12 SCI papers and/or patents and establishing an auxiliary diagnosis platform for both clinical and academic purposes. The findings will offer new insights into the pathogenetic mechanisms, improving early detection, diagnosis, and treatment, ultimately advancing precision medicine for ASD.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impression

  The CGI-S (Clinical Global Impression-Severity Scale) and CGI-I (-Improvement Scale) are single-item ratings of the clinician's assessment of the global severity of clinical symptoms. Severity and improvement are rated on a 7-point scale (from 1 = normal, not at all ill, to 7 = among the most extremely ill) and (from 1 = very much improved, to 7 = very much worse).

  At baseline (before treatment, V0), month 1 (V1), month 2 (V2), month 3 (V3), month 4 (V4), and month 6 (V5)

• Social Responsiveness Scale (SRS)

  The SRS is a 65-item questionnaire based on parent-reports on the child's social interactions with others (rating 0-3), consists of 5 subscales: social awareness, social cognition, social communication, social motivation, and autistic mannerisms

  At baseline (before treatment, V0), month 1 (V1), month 2 (V2), month 3 (V3), month 4 (V4), and month 6 (V5)

Secondary Outcomes (3)

• Self-administered questionnaires

  At baseline (before treatment, V0), month 3 (V3), and month 6 (V5)

• Neuropsychological functions: Continuous Performance Test(CPT)

  At baseline (before treatment, V0), month 3 (V3), and month 6 (V5)

• Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)

  At baseline (before treatment, V0), month 3 (V3), and month 6 (V5)

Study Arms (2)

GKB7

EXPERIMENTAL

Other: probiotic (GKB7/placebo)

Placebo

PLACEBO COMPARATOR

Other: probiotic (GKB7/placebo)

Interventions

probiotic (GKB7/placebo) OTHER

The objectives of this double-blind randomized placebo-controlled trial are to evaluate the tolerability, safety, and efficacy of the probiotic intervention with Clostridium butyricum GKB7 among 90 4-15-year-old children and adolescents with a clinical diagnosis of ASD according to the DSM-5

GKB7; Placebo

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Susan Shur-Fen Gau, MD, PhD

CONTACT

+886-2-23123456; gaushufe@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2028
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

TW (1)