StrokeNCT06479915
Estimate the Relationship Between Oral Microbiota and Stroke
An observational study of Stroke and Microbial Disease, run by Fujian Medical University at 2 sites in China.
Trial summary
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Microbial Disease
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2024to 30 Jun 2025
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: small cerebral vessel disease
Who may be able to join
- 1. Microbleeding/damage or rupture of small blood vessels in the brain has been diagnosed within the past 365 days 2. Have done nuclear magnetic examination and can provide nuclear magnetic results
Who cannot join
- Have received antibiotic quality within the last three months
Trial locations and contacts
2 sites in 1 country.
China2 sites
School and Hospital of stomatology,Fujian Medical University,Fuzhou,Fujian Province,350002,China
Fuzhou, Fujian, 350002
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350002
About this study
Official title: Access the Influence of Oral Microbiota in the Onset and Evolution of Stroke, With Focus on Cerebral Microbleeds
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Furthermore, in cases of oral inflammatory diseases, SM has been found to invade the bloodstream and disseminate, leading to systemic diseases. Against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups.
Read the detailed description
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Furthermore, in cases of oral inflammatory diseases, SM has been found to invade the bloodstream and disseminate, leading to systemic diseases. Against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups. The objective of this study is to offer novel insights into the association between oral health and cerebrovascular disease occurrence while establishing a foundation for future research.
- Conditions
- Stroke, Microbial Disease
- Keywords
- cnm, Streptococcus mutans, Cerebal microbleeds, Cerebral hemorrhage, Cerebral ischemia, cnm-positive streptococcus mutans
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Brain Ischemia
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 |
|---|---|---|
| Stroke | Small cerebral vessel disease | |
| healthy people | MRI showed no signs of small cerebral vessel disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the Relationship Between Oral Microbiota and Stroke
Measure the diversity and abundance of oral bacteria in stroke patients,units:Number of bacterial species, bacterial counts (CFU/ml)
Measured: 2025.06
Correlation Between Oral Microbiota and Cerebral Microbleeds in Stroke
Number and volume of microbleeds (measured in mm³)
Measured: 2025.06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Apr 2024
- Primary completion28 Feb 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University
- Responsible party
- Principal investigator, Xiaojing Huang, Fujian Medical University
- Investigators
- XiaoJing Huang, Study chair, School and Hospital of Stomatology,Fujian Medical University,fuzhou,Fujian Province,350002,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479915
- Sponsor's protocol ID
- SHFMU
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access the Influence of Oral Microbiota in the Onset and Evolution of Stroke, With Focus on Cerebral Microbleeds
- ClinicalTrials.gov ID
- NCT06479915
- Acronym / sponsor ID
- SHFMU
- Conditions
- Stroke, Microbial Disease
- Keywords
- cnm, Streptococcus mutans, Cerebal microbleeds, Cerebral hemorrhage, Cerebral ischemia, cnm-positive streptococcus mutans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Jun 2024 (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.
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Furthermore, in cases of oral inflammatory diseases, SM has been found to invade the bloodstream and disseminate, leading to systemic diseases. Against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups.
Detailed description
Oral bacteria constitute the second largest population of the human microbiome. Recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. Streptococcus Mutans (SM) is considered the primary pathogen responsible for dental caries. Furthermore, in cases of oral inflammatory diseases, SM has been found to invade the bloodstream and disseminate, leading to systemic diseases. Against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups. The objective of this study is to offer novel insights into the association between oral health and cerebrovascular disease occurrence while establishing a foundation for future research.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Small cerebral vessel disease |
| healthy people | – | –MRI showed no signs of small cerebral vessel disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- small cerebral vessel disease
Key inclusion criteria (1 listed)
- 1. Microbleeding/damage or rupture of small blood vessels in the brain has been diagnosed within the past 365 days 2. Have done nuclear magnetic examination and can provide nuclear magnetic results
Key exclusion criteria (1 listed)
- Have received antibiotic quality within the last three months
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
Estimate the Relationship Between Oral Microbiota and Stroke
Time frame: 2025.06
Measure the diversity and abundance of oral bacteria in stroke patients,units:Number of bacterial species, bacterial counts (CFU/ml)
Correlation Between Oral Microbiota and Cerebral Microbleeds in Stroke
Time frame: 2025.06
Number and volume of microbleeds (measured in mm³)
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 7 Aug 2025.
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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.
XiaoJing Huang study chair
School and Hospital of Stomatology,Fujian Medical University,fuzhou,Fujian Province,350002,China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Microbial Disease, run by Fujian Medical University at 2 sites 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 1 inclusion and 1 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Estimate the Relationship Between Oral Microbiota and Stroke (time frame: 2025.06). The study lists 2 primary outcomes in all. 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 7 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.