AutismNCT07538232
Oral Microecology in Children With Autism
An observational study of Autism and Caries,Dental, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism, Caries,Dental
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2024to 20 Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Child, Adult
Study population: children with autism aged 6-18 years old
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Stomatology, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
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
Read the detailed description
- 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.
- Conditions
- Autism, Caries,Dental
- Medical subject headings
- Autistic Disorder, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| autism group | children with autism aged 6-18 years | |
| TD group | typically developed children aged 6-18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
sequencing of 16s rRNA
sequencing of 16s rRNA
Measured: 2024-2026
Secondary outcomes (2)
IgA
IgA of saliva
Measured: 2024-2026
DMFT/dmeft
decayed, missing, filled teeth
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start24 Nov 2024
- Primary completion20 Sep 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538232
- Sponsor's protocol ID
- 2024-152（R）
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Microecology in Children With Autism
- ClinicalTrials.gov ID
- NCT07538232
- Acronym / sponsor ID
- 2024-152（R）
- Conditions
- Autism, Caries,Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autism group | – | –children with autism aged 6-18 years |
| TD group | – | –typically developed children aged 6-18 years |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children with autism aged 6-18 years old
Key inclusion criteria (2 listed)
- Clear source: This project is supported by the Affiliated Dental Hospital of Zhejiang University School of Medicine;
Key exclusion criteria (4 listed)
- Magnetic resonance imaging detected significant abnormalities in brain structure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sequencing of 16s rRNA
Time frame: 2024-2026
sequencing of 16s rRNA
2 secondary outcomes
IgA
Time frame: 2024-2026
DMFT/dmeft
Time frame: 2024-2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Caries,Dental, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sequencing of 16s rRNA (time frame: 2024-2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.