Skip to content

Oral Microecology in Children With Autism

Oral Microecology in Children With Autism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07538232
Enrollment
380
Registered
2026-04-20
Start date
2024-11-24
Completion date
2026-03-20
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Caries,Dental

Brief summary

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

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.

Interventions

None listed

Sponsors

The Dental Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
sequencing of 16s rRNA2024-2026sequencing of 16s rRNA

Secondary

MeasureTime frameDescription
IgA2024-2026IgA of saliva
DMFT/dmeft2024-2026decayed, missing, filled teeth

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026