NCT06479915

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

June 19, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

cnmStreptococcus mutansCerebal microbleedsCerebral hemorrhageCerebral ischemiacnm-positive streptococcus mutans

Outcome Measures

Primary Outcomes (2)

  • 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)

    2025.06

  • Correlation Between Oral Microbiota and Cerebral Microbleeds in Stroke

    Number and volume of microbleeds (measured in mm³)

    2025.06

Study Arms (2)

Stroke

Small cerebral vessel disease

healthy people

MRI showed no signs of small cerebral vessel disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

small cerebral vessel disease

You may qualify if:

  • \. 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

You may not qualify if:

  • Have received antibiotic quality within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School and Hospital of stomatology,Fujian Medical University,Fuzhou,Fujian Province,350002,China

Fuzhou, Fujian, 350002, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350002, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva;dental plaque

MeSH Terms

Conditions

StrokeCerebral HemorrhageBrain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • XiaoJing Huang

    School and Hospital of Stomatology,Fujian Medical University,fuzhou,Fujian Province,350002,China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Archiater

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 28, 2024

Study Start

April 1, 2024

Primary Completion

February 28, 2025

Study Completion

June 30, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations