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.

NCT04795687 | Unknown

• 1 other identifier: IIBSP-MAE-2020-12
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Gut microbiota; Stroke; Metagenomics

Outcome Measures

Primary Outcomes (1)

• Risk of stroke and disability after a stroke

  Use of the Modified Rankin Scale (mRS), evaluted from 0 to 6 (where higher scores mean worse outcome), to asses disability in patients who have suffered a stroke and comparison over time to check for recovery and degree of continued disability

  3 months

Study Arms (2)

Ischemic stroke patients

Control

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

Samples will be collected from those patients with ischemic stroke who attend the Hospital de la Santa Creu i Sant Pau while the study is carried out.

You may qualify if:

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

You may not qualify if:

• Patients under 18 years of age.
• Additional serious illness or unstable medical condition.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Institut de Recerca Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40686474 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and fecal samples stored with ethanol 96%.

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Israel Fernández Cadenas, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Lledós, MSc

CONTACT

+34679815196; mlledos@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: July 15, 2020
• Primary Completion: July 15, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.
• Access Criteria: IPD will be shared for further analysis under request. Requests will be reviewed by the overall study official Dr. Israel Fernández Cadenas.

Locations

ES (1)