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Completed

NCT Number: NCT07538232

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

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, China

About this study

  • 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".

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. sequencing of 16s rRNA

    Time frame: 2024-2026

    sequencing of 16s rRNA

Secondary outcomes

  1. IgA

    Time frame: 2024-2026

    IgA of saliva

  2. DMFT/dmeft

    Time frame: 2024-2026

    decayed, missing, filled teeth

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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