Discovering Patterns in the Gut Microbiota Associated With the Risk of Stroke and the Outcome After a Stroke and Integration of These Data With Genomic Information to Find New Drug Targets and New Treatments to Improve Neurological Evolution and Functional Status of Stroke Patients.
NCT ID: NCT04795687
Last Updated: 2021-09-21
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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UNKNOWN
300 participants
OBSERVATIONAL
2020-07-15
2022-12-31
Brief Summary
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For the study, samples will be collected from those patients with ischemic stroke who come to the hospital while the study is being carried out, taking into account certain criteria: the patients must be over 18 years of age, have suffered an ischemic stroke (demonstrated by resonance or head CT), not have any additional serious illness or unstable medical condition, and not be included in clinical trials with neuroprotective drugs. On the other hand, the control group will be asymptomatic, and will be made up of people who have not previously suffered a stroke or a cardiovascular event and who do not have diseases that affect the digestive tract.
The main variables of the study are the risk of stroke and disability after a cerebrovascular accident (measured by mRS at 3rd month). Microbiota, genetic and epigenetic variables are also taken into account, such as the presence and levels of bacteria, dysbiosis, genetic polymorphisms and levels of methylation in CpG islands.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Ischemic stroke patients
No interventions assigned to this group
Control
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Additional serious illness or unstable medical condition.
* Inclusion in clinical trials with neuroprotective drugs.
18 Years
ALL
Yes
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Israel Fernández Cadenas, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Institut de Recerca Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Lledos M, Prats-Sanchez L, Muino E, Cullell N, Llucia-Carol L, Carcel-Marquez J, Gallego-Fabrega C, Martin-Campos JM, Marin R, Aguilera-Simon A, Guasch-Jimenez M, Ezcurra-Diaz G, Camps-Renom P, Del Mar Freijo M, Marti-Fabregas J, Fernandez-Cadenas I. Influence of the Gut Microbiota on Acute Ischemic Stroke Functional Outcomes at Three Months. Eur J Neurol. 2025 Jul;32(7):e70265. doi: 10.1111/ene.70265.
Other Identifiers
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IIBSP-MAE-2020-12
Identifier Type: -
Identifier Source: org_study_id
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