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临床试验/NCT07538232
NCT07538232已完成不适用

Oral Microecology in Children With Autism

The Dental Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2024年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
380
试验地点
1
主要终点
sequencing of 16s rRNA

研究概览

简要总结

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

详细描述

  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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

autism group

children with autism aged 6-18 years

TD group

typically developed children aged 6-18 years

结局指标

主要结局

sequencing of 16s rRNA

时间窗: 2024-2026

sequencing of 16s rRNA

次要结局

  • IgA(2024-2026)
  • DMFT/dmeft(2024-2026)

研究者

发起方
The Dental Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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