The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study
NCT ID: NCT04803838
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
290 participants
OBSERVATIONAL
2018-01-01
2026-08-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patiens
Patients With symptomatic or asymptomatic carotid stenosis (\> 50%, NASCET criteria)
No intervention
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.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* current antibiotic treatment
* autoimmune or autoinflammatory disease
* malignancies
18 Years
ALL
Yes
Sponsors
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University of Oslo
OTHER
University Hospital, Akershus
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Mona Skjelland
Clinical Professor
Locations
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Oslo University Hospital
Oslo, Oslo County, Norway
Countries
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Other Identifiers
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REK 2017/2202
Identifier Type: -
Identifier Source: org_study_id
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