StrokeNCT07357155
Oral and Salivary Biomarkers Associated With Stroke
An observational study of Stroke, run by University Hospital Center (CHU) of Constantine, Algeria at 2 sites in Algeria.
Trial summary
This observational study aims to investigate associations between oral and salivary biomarkers and stroke. Adults with stroke and healthy controls will undergo clinical oral assessment and unstimulated saliva collection. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 120 participants
- Where
- 2 sitesAlgeria
- Study dates
- 20 Dec 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.
Who may be able to join
- Adults aged 18 to 90 years.
- Patients diagnosed with stroke (ischemic or hemorrhagic) confirmed by clinical and imaging criteria for the stroke group.
- Healthy volunteers without a history of stroke or cerebrovascular disease for the control group.
- Ability to provide written informed consent.
Who cannot join
- inflammatory disease at the time of sampling.
- Chronic autoimmune or malignant disease.
- Recent major surgery or trauma within the last 3 months.
- Pregnancy or breastfeeding.
- Inability or refusal to provide saliva samples.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria2 sites
Private Dental Clinic, Constantine
Constantine, 25000
University Hospital Center (CHU) of Constantine
Constantine, 25017
Boubekeur seddik Fekraoui, Professor, 0559375365, neurology.departement25@gmail.com
About this study
Official title: An Observational Study of Oral and Salivary Biomarkers Associated With Stroke
This observational study aims to investigate associations between oral and salivary biomarkers and stroke. Adults with stroke and healthy controls will undergo clinical oral assessment and unstimulated saliva collection. Salivary inflammatory biomarkers and oral bacterial profiles will be analyzed, including detection of Streptococcus mutans and the cnm gene by PCR/qPCR. The study will explore associations between these biomarkers and stroke status.
Read the detailed description
Stroke is a major cause of morbidity and mortality worldwide. Growing evidence suggests that oral health, oral bacterial profiles, and salivary biomarkers may be associated with systemic inflammatory and vascular conditions.
This observational case-control study is designed to evaluate associations between oral clinical findings, salivary inflammatory biomarkers, oral bacterial profiles, and stroke. Adults with a confirmed diagnosis of ischemic or hemorrhagic stroke and healthy controls will be enrolled. Data collection will include demographic and medical information, oral examination findings, and unstimulated saliva samples.
Salivary samples will be analyzed for inflammatory and biochemical biomarkers and oral bacterial DNA. Molecular analysis will include detection of Streptococcus mutans and the cnm gene using PCR/qPCR. The prevalence of Cnm-positive Streptococcus mutans will be compared between stroke patients and healthy controls and explored in relation to cerebrovascular characteristics.
Stroke patients will be prospectively followed for 90 days after the index stroke. Functional outcome at 90 days will be assessed using the modified Rankin Scale (mRS). Associations between baseline oral and salivary biomarkers, including Cnm-positive Streptococcus mutans status, and 90-day functional outcome will be explored.
This study is observational and involves no therapeutic or experimental intervention.
Study Team: This study is led by Dr. Abdeldjalil Zitouni (Principal Investigator) in collaboration with:
Prof. Fekraoui Boubakeur seddik, Head of the Department of Neurology, Prof. Serradj Fatima, Assistant Professor of Neurology, and Dr. Boutbiba Ikrame, Assistant of Neurology, at the University Hospital Center (CHU) of Constantine, Algeria.
- Conditions
- Stroke
- Keywords
- Stroke, Oral health, Salivary biomarkers, Cerebrovascular disease, Observational study, Streptococcus mutans, Cnm-positive Streptococcus mutans, Cnm gene, Oral microbiota
- Medical subject headings
- Stroke, Cerebrovascular Disorders
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 group | Patients diagnosed with stroke. | |
| Healthy control group | Healthy participants without a history of stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.
Assessment of salivary inflammatory and neuroendocrine biomarkers, including salivary cortisol and selected inflammatory cytokines (e.g., IL-6 and/or hs-CRP), to identify biomarker patterns associated with stroke.
Measured: Single time-point assessment at enrollment
Secondary outcomes (3)
Exploratory association between oral microbiota profiles and stroke status
Exploratory analysis of the association between oral microbiota profiles and stroke status using saliva or oral swab samples. The analysis aims to identify bacterial profiles potentially associated with stroke and oral-systemic interactions.
Measured: Single time-point assessment at enrollment
Association between salivary Cnm-positive Streptococcus mutans and stroke status
Detection of Streptococcus mutans and the cnm gene in unstimulated saliva using PCR/qPCR. The prevalence of Cnm-positive Streptococcus mutans will be compared between stroke patients and healthy controls to evaluate its association with stroke status.
Measured: Single time-point assessment at enrollment
Functional outcome at 90 days after stroke
Functional outcome will be assessed at 90 days after stroke using the modified Rankin Scale (mRS). The association between baseline oral and salivary biomarkers, including Cnm-positive Streptococcus mutans status, and 90-day functional outcome will be explored.
Measured: 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Dec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center (CHU) of Constantine, Algeria
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdeldjalil ZITOUNI, University Hospital Center (CHU) of Constantine, Algeria
- Investigators
- Abdeldjalil Zitouni, DDS, Principal investigator, Independent Researcher, Constantine, Algeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357155
- Sponsor's protocol ID
- CHU-STROKE-001
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Publications
Miyatani F, et al. Collagen-binding activity of Streptococcus mutans and cerebral microbleeds. Stroke. 2015.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Oral and Salivary Biomarkers Associated With Stroke
- ClinicalTrials.gov ID
- NCT07357155
- Acronym / sponsor ID
- CHU-STROKE-001
- Conditions
- Stroke
- Keywords
- Stroke, Oral health, Salivary biomarkers, Cerebrovascular disease, Observational study, Streptococcus mutans, Cnm-positive Streptococcus mutans, Cnm gene
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital Center (CHU) of Constantine, AlgeriaOther government
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Jan 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 observational study aims to investigate associations between oral and salivary biomarkers and stroke. Adults with stroke and healthy controls will undergo clinical oral assessment and unstimulated saliva collection. Salivary inflammatory biomarkers and oral bacterial profiles will be analyzed, including detection of Streptococcus mutans and the cnm gene by PCR/qPCR. The study will explore associations between these biomarkers and stroke status.
Detailed description
Stroke is a major cause of morbidity and mortality worldwide. Growing evidence suggests that oral health, oral bacterial profiles, and salivary biomarkers may be associated with systemic inflammatory and vascular conditions.
This observational case-control study is designed to evaluate associations between oral clinical findings, salivary inflammatory biomarkers, oral bacterial profiles, and stroke. Adults with a confirmed diagnosis of ischemic or hemorrhagic stroke and healthy controls will be enrolled. Data collection will include demographic and medical information, oral examination findings, and unstimulated saliva samples.
Salivary samples will be analyzed for inflammatory and biochemical biomarkers and oral bacterial DNA. Molecular analysis will include detection of Streptococcus mutans and the cnm gene using PCR/qPCR. The prevalence of Cnm-positive Streptococcus mutans will be compared between stroke patients and healthy controls and explored in relation to cerebrovascular characteristics.
Stroke patients will be prospectively followed for 90 days after the index stroke. Functional outcome at 90 days will be assessed using the modified Rankin Scale (mRS). Associations between baseline oral and salivary biomarkers, including Cnm-positive Streptococcus mutans status, and 90-day functional outcome will be explored.
This study is observational and involves no therapeutic or experimental intervention.
Study Team: This study is led by Dr. Abdeldjalil Zitouni (Principal Investigator) in collaboration with:
Prof. Fekraoui Boubakeur seddik, Head of the Department of Neurology, Prof. Serradj Fatima, Assistant Professor of Neurology, and Dr. Boutbiba Ikrame, Assistant of Neurology, at the University Hospital Center (CHU) of Constantine, Algeria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | –Patients diagnosed with stroke. |
| Healthy control group | – | –Healthy participants without a history of stroke. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from multiple regions within Algeria, reflecting a diverse national population.
Key inclusion criteria (4 listed)
- Adults aged 18 to 90 years.
- Patients diagnosed with stroke (ischemic or hemorrhagic) confirmed by clinical and imaging criteria for the stroke group.
- Healthy volunteers without a history of stroke or cerebrovascular disease for the control group.
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- inflammatory disease at the time of sampling.
- Chronic autoimmune or malignant disease.
- Recent major surgery or trauma within the last 3 months.
- Pregnancy or breastfeeding.
- Inability or refusal to provide saliva samples.
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
Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls.
Time frame: Single time-point assessment at enrollment
Assessment of salivary inflammatory and neuroendocrine biomarkers, including salivary cortisol and selected inflammatory cytokines (e.g., IL-6 and/or hs-CRP), to identify biomarker patterns associated with stroke.
3 secondary outcomes
Exploratory association between oral microbiota profiles and stroke status
Time frame: Single time-point assessment at enrollment
Association between salivary Cnm-positive Streptococcus mutans and stroke status
Time frame: Single time-point assessment at enrollment
Functional outcome at 90 days after stroke
Time frame: 90 days after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- BackgroundMiyatani F, et al. Collagen-binding activity of Streptococcus mutans and cerebral microbleeds. Stroke. 2015.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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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.
Abdeldjalil Zitouni, DDS principal investigator
Independent Researcher, Constantine, Algeria
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, run by University Hospital Center (CHU) of Constantine, Algeria at 2 sites in Algeria.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Algeria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdeldjalil Zitouni, DDS (+213550400202, djalil007_dz@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in salivary inflammatory biomarker profiles between stroke patients and healthy controls. (time frame: Single time-point assessment at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357155, which also lists 1 linked publication.
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 8 Oct 2026.