The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study

NCT04803838 | Active Not Recruiting

• 1 other identifier: REK 2017/2202
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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 microbiota. The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis.

Conditions

Ischemic Stroke; Atherosclerosis; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  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.

  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.

  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.

  At inclusion

Study Arms (2)

Patiens

Patients With symptomatic or asymptomatic carotid stenosis (\> 50%, NASCET criteria)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Controls; Patiens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \- patients \>18 years with an symptomatic og asymptomatic atherosclerotic carotid stenosis ≥ 50% (NASCET criteria)

You may not qualify if:

• active infection
• current antibiotic treatment
• autoimmune or autoinflammatory disease
• malignancies

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• University Hospital, Akershus: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Feces Saliva Carotid plaque

MeSH Terms

Conditions

Ischemic Stroke; Atherosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: March 18, 2021
• Study Start: January 1, 2018
• Primary Completion: December 19, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-04

Locations

NO (1)