Oral Microecology in Children With Autism

This study is a non-interventional research aimed at investigating the oral microbiota distribution and salivary IgA in children with autism by collecting dental plaque and saliva for analysis, without involving experimental content

Study Overview

• Status: Completed
• Conditions: Autism; Caries,Dental

Detailed Description

1. Research Background Autism spectrum disorder (ASD) is a pervasive developmental disorder that has become the leading cause of mental disability in children in China. The onset of autism is closely related to genetic factors and environmental factors in early development. In recent years, studies have found that changes in gut microbiota are related to the pathogenesis of ASD.

   Salivary immunoglobulin A (IgA) is the main protective antibody in oral mucosal immunity, which, together with the innate immune system, inhibits the adhesion of microorganisms to the mucosa and tooth surface, promotes the elimination of cariogenic microorganisms such as Streptococcus mutans. Given the changes in oral health status in ASD patients and the correlation between oral microbiota dysbiosis and mucosal immunity, the level of salivary IgA affected by oral bacteria may vary in ASD subjects.

   Oral microbiota may have direct or indirect effects on the brain. Bacteria can enter the bloodstream through mucous membranes and tooth roots, break through the blood-brain barrier, and enter the brain; Oral associated bacteria can also promote the elevation of inflammatory factors in cerebrospinal fluid and affect the levels of neurotransmitters involved in learning and memory. There may be a certain connection between oral microbiota and the brain in children with ASD, with a "microbiota mouth brain axis".

2. Research objective

   • Clarify the changes in IgA content and oral microbiota abundance in children with varying degrees of ASD; ② Clarify the changes in IgA content and oral microbiota abundance between ASD children and normal children groups; ③ Clarify the host's immune response under changes in oral microbiota.

• Study Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

children with autism aged 6-18 years old

Description

Inclusion Criteria:

• Clear source: This project is supported by the Affiliated Dental Hospital of Zhejiang University School of Medicine;

  • Make sure to collect all patients' age, gender, and basic test information. The age range is 6-18 years old, and there is no restriction on gender; ③ The subjects and/or their families are able to understand the purpose of the trial, are willing to cooperate, and voluntarily or/and with the consent of their families, agree to participate in the trial and sign the informed consent form.

Exclusion Criteria:

• Magnetic resonance imaging detected significant abnormalities in brain structure;

  • Severe sensory organ damage (blindness, hearing loss); ③ Having organic gastrointestinal problems;

    • Taking antibiotics or immunosuppressive drugs within one month;

      • Autism and other conditions that have been clearly linked to genetics; ⑥ Obvious abnormalities in oral mucosa; ⑦ Wearing various orthodontic appliances and accessories.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
autism group; children with autism aged 6-18 years
TD group; typically developed children aged 6-18 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sequencing of 16s rRNA	sequencing of 16s rRNA	2024-2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgA	IgA of saliva	2024-2026
DMFT/dmeft	decayed, missing, filled teeth	2024-2026

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2024
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Stomatognathic Diseases; Mental Disorders; Tooth Diseases; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Tooth Demineralization; Autistic Disorder; Dental Caries
• Other Study ID Numbers: 2024-152（R）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No