Ischemic StrokeNCT04803838
The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study
An observational study of Ischemic Stroke and Atherosclerosis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke. The investigators aim to show that these metabolite levels are diet-dependent (mainly egg yalk and red meat) and associated with specific types of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Atherosclerosis, Microbiota
- How many people
- 290 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 1 Aug 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - All patients >18 years with an atherosclerotic carotid stenosis ≥ 50% admitting our department (Dep of Neurology, Rikshospitalet, OUH) as in-patient or out-patient will consecutively be considered for inclusion. Cooperation With Dep of vascular surgery Akershus University Hospital and Dep of vascular surgery, Aker, OUH, for patients scheduled for thrombendarterectomy. - Control Group: For study 1: Healthy volonteers For study 2 and 3: Spouses/partners where possible, otherwise matched for age and sex
Who may be able to join
- patients >18 years with an symptomatic og asymptomatic atherosclerotic carotid stenosis ≥ 50% (NASCET criteria)
Who cannot join
- active infection
- current antibiotic treatment
- autoimmune or autoinflammatory disease
- malignancies
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke.
The investigators aim to show that these metabolite levels are diet-dependent (mainly egg yalk and red meat) and associated with specific types of microbiota.
The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis.
Read the detailed description
The Project will include four studies:
Study 1: (Comparative cross-sectional study) The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls.
This study will be done on prospectively collected information already available in our existing database. Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified. These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis (verified by ultrasound), cardiovascular outcome defined as stroke/TIA or vascular death, as well as traditional risk factors for ischemic stroke (diabetes, hypertension, smoking and coronary artery disease).
Study 2: (Comparative cross-sectional study) The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet, in particular Rich in red meat and egg yalk.
In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by 'Lipidklinikken Rikshospitalet'. Feces, saliva and blood will be collected analyzed for microbiota and metabolites. Antroprometrics, blood pressure and pulse will be recorded.
In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done.
Study 3: (Comparative cross-sectional study) The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood, as well as known risk factors for stroke and inflammation on imaging modalities (ultrasound, 3-T MRI and PET/CT) .
In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls.
Patients will undergo investigations with carotid ultrasound, carotid and cerebral MR imaging, blood tests including inflammatory biomarkers. A sub-group of patients will in addition undergo PET/CT imaging of carotid arteries.
Study 4: (Follow up study) The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis.
Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations. Findings with serum levels of microbiota metabolites, traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression.
- Conditions
- Ischemic Stroke, Atherosclerosis, Microbiota
- Being tested
- No intervention
- Medical subject headings
- Ischemic Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patiens | Patients With symptomatic or asymptomatic carotid stenosis (> 50%, NASCET criteria) Receives: Other: No intervention | |
| Controls | For study 1: Healthy Controls, volunters (mostly blood donors) For study 2 and 3: Spouses/someone living in the same household as the patient. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants With MRI-confirmed acute ischemic stroke related to increased Levels of serum microbiota-metabolites as assessed by blood tests.
Blood test (microbiota-metabolites e.g. TMAO) at study inclusion, carotid ultrasound (carotid plaque assessment and degree of stenosis) and cerebral MRI (evidence of stroke) at follow up
Measured: 2 years
Secondary outcomes (5)
Number of participants with progression of carotid stenosis related to increased Levels of serum microbiota-metabolites as assessed by blood tests.
Blood tests (microbiota metabolites e.g. TMAO) and carotid ultrasound (plaque assessment and degree of stenosis)
Measured: 2 years
Number of participants With increased Levels of microbiota-metabolites related to Diet Rich in red meat and egg yalk as assessed by 'Smart Diet' questionnaire.
Blood tests (microbiota metabolites, e.g. TMAO), dietary questionnaire ('Smart Diet' developed by the department for endocrinology Rikshospitalet)
Measured: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to specific types of microbiota in feces and saliva as assessed by next generation sequencing and 16S RNA.
Blood tests (microbiota metabolites e.g TMAO), fecal samples (Next generation sequencing, 16S RNA), saliva samples (Next generation sequencing 16S RNA)
Measured: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to traditional risk factors for ischemic stroke assessed by questionnaire and Medical journal.
Blood tests (microbiota metabolites, e.g. TMAO), questionnaire (Risk factors: hypertension, diabetes mellitus type 2, previous stroke og myocardial infarction, smoking, physical inactivity, Family history)
Measured: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to signs of plaque instability on imaging studies assessed by carotid ultrasound, carotid and cerebral MRI and for a subgroup: carotid PET/CT.
Blood tests (microbiota metabolites, e.g. TMAO), carotid ultrasound (carotid plaque assessment, degree of stenosis), carotid and cerebral MRI (evidence of inflammation and stenosis in carotids, stroke), for a subgroup: carotid PET/CT (evidence of inflammation)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jan 2018
- Primary completion19 Dec 2024
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus
- Responsible party
- Principal investigator, Mona Skjelland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803838
- Sponsor's protocol ID
- REK 2017/2202
- Status last verified
- Apr 2025
- First submitted
- 10 Sep 2018
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study
- ClinicalTrials.gov ID
- NCT04803838
- Acronym / sponsor ID
- REK 2017/2202
- Conditions
- Ischemic Stroke, Atherosclerosis, Microbiota
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Mar 2021 (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.
The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke.
The investigators aim to show that these metabolite levels are diet-dependent (mainly egg yalk and red meat) and associated with specific types of microbiota.
The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis.
Detailed description
The Project will include four studies:
Study 1: (Comparative cross-sectional study) The main objective in this study is to assess if patients with carotid atherosclerosis have increased serum levels gut microbiota dependent metabolites compared to healthy controls.
This study will be done on prospectively collected information already available in our existing database. Approximately 215 patients will be included in this study where collected samples will be analyzed and levels of metabolites quantified. These metabolite levels will be compared to a control group of 70 healthy controls without carotid atherosclerosis (verified by ultrasound), cardiovascular outcome defined as stroke/TIA or vascular death, as well as traditional risk factors for ischemic stroke (diabetes, hypertension, smoking and coronary artery disease).
Study 2: (Comparative cross-sectional study) The aim of this study is to asses if microbiota and microbiota metabolite Levels are Associated With certain types of diet, in particular Rich in red meat and egg yalk.
In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls. Dietary intake and food habits will be recorded using the SmartDiet questionnaire developed by 'Lipidklinikken Rikshospitalet'. Feces, saliva and blood will be collected analyzed for microbiota and metabolites. Antroprometrics, blood pressure and pulse will be recorded.
In patients undergoing carotid endarterectomy and immunohistochemical analysis will be done.
Study 3: (Comparative cross-sectional study) The aim of this study is to evaluate correlation between the microbiota and microbiota metabolite Levels With other inflammatory markers in blood, as well as known risk factors for stroke and inflammation on imaging modalities (ultrasound, 3-T MRI and PET/CT) .
In this study, 215 patients with ultrasound verified carotid atherosclerosis with or without symptoms of TIA/stroke will be compared to 70 controls.
Patients will undergo investigations with carotid ultrasound, carotid and cerebral MR imaging, blood tests including inflammatory biomarkers. A sub-group of patients will in addition undergo PET/CT imaging of carotid arteries.
Study 4: (Follow up study) The aim of this study is to evaluate the ability of microbiota and microbiota metabolites to predict ischemic stroke in patient With carotid stenosis.
Patients in study 2 and 3 will be followed up after 2 years with repetition of investigations. Findings with serum levels of microbiota metabolites, traditional risk factors and imaging will be correlated to clinical and radiological ischemic events and plaque progression.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patiens | – | Other: No interventionPatients With symptomatic or asymptomatic carotid stenosis (> 50%, NASCET criteria) |
| Controls | – | Other: No interventionFor study 1: Healthy Controls, volunters (mostly blood donors) For study 2 and 3: Spouses/someone living in the same household as the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - All patients >18 years with an atherosclerotic carotid stenosis ≥ 50% admitting our department (Dep of Neurology, Rikshospitalet, OUH) as in-patient or out-patient will consecutively be considered for inclusion. Cooperation With Dep of vascular surgery Akershus University Hospital and Dep of vascular surgery, Aker, OUH, for patients scheduled for thrombendarterectomy. - Control Group: For study 1: Healthy volonteers For study 2 and 3: Spouses/partners where possible, otherwise matched for age and sex
Key inclusion criteria (1 listed)
- patients >18 years with an symptomatic og asymptomatic atherosclerotic carotid stenosis ≥ 50% (NASCET criteria)
Key exclusion criteria (4 listed)
- active infection
- current antibiotic treatment
- autoimmune or autoinflammatory disease
- malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Controls, Patiens |
Primary outcome
Number of participants With MRI-confirmed acute ischemic stroke related to increased Levels of serum microbiota-metabolites as assessed by blood tests.
Time frame: 2 years
Blood test (microbiota-metabolites e.g. TMAO) at study inclusion, carotid ultrasound (carotid plaque assessment and degree of stenosis) and cerebral MRI (evidence of stroke) at follow up
5 secondary outcomes
Number of participants with progression of carotid stenosis related to increased Levels of serum microbiota-metabolites as assessed by blood tests.
Time frame: 2 years
Number of participants With increased Levels of microbiota-metabolites related to Diet Rich in red meat and egg yalk as assessed by 'Smart Diet' questionnaire.
Time frame: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to specific types of microbiota in feces and saliva as assessed by next generation sequencing and 16S RNA.
Time frame: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to traditional risk factors for ischemic stroke assessed by questionnaire and Medical journal.
Time frame: At inclusion
Number of participants With increased Levels of microbiota-metabolites related to signs of plaque instability on imaging studies assessed by carotid ultrasound, carotid and cerebral MRI and for a subgroup: carotid PET/CT.
Time frame: At inclusion
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 Ischemic Stroke and Atherosclerosis, run by Oslo University Hospital at 1 site in Norway.
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 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 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 Norway. 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?
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?
Number of participants With MRI-confirmed acute ischemic stroke related to increased Levels of serum microbiota-metabolites as assessed by blood tests. (time frame: 2 years). 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 Jan 2026.