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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-12-31

Brief Summary

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The composition of the intestinal microbiota is associated with the risk of stroke and with post-stroke neurological evolution. At the same time, the genetics and epigenetics of each patient are associated with the composition of the intestinal microbiota. The study of the microbiome in stroke patients will allow finding new therapeutic targets for the treatment of stroke patients.

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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Patients with ischemic stroke (demonstrated by resonance or head CT).

Exclusion Criteria

* Patients under 18 years of age.
* Additional serious illness or unstable medical condition.
* Inclusion in clinical trials with neuroprotective drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Miquel Lledós, MSc

Role: CONTACT

+34679815196

Facility Contacts

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Miquel Lledós, MSc

Role: primary

+34679815196

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.

Reference Type DERIVED
PMID: 40686474 (View on PubMed)

Other Identifiers

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IIBSP-MAE-2020-12

Identifier Type: -

Identifier Source: org_study_id

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