Ischemic StrokeMAESTRONCT04795687
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.
An observational study of Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients with ischemic stroke (demonstrated by resonance or head CT).
Who cannot join
- Patients under 18 years of age.
- Additional serious illness or unstable medical condition.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut de Recerca Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Miquel Lledós, MSc, +34679815196, mlledos@santpau.cat
About this study
Official title: Association of Metagenomics and Transcriptomics With the Appearance and Evolution of an Ischemic Stroke
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
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke patients | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start15 Jul 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Israel Fernández Cadenas, PhD, Principal investigator, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795687
- Sponsor's protocol ID
- IIBSP-MAE-2020-12
- Acronym
- MAESTRO
- Status last verified
- Sep 2021
- First submitted
- 10 Mar 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD).
Publications
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.
PubMed 40686474Lledos M, Prats-Sanchez L, Llucia-Carol L, Carcel-Marquez J, Muino E, Cullell N, Gallego-Fabrega C, Martin-Campos JM, Aguilera-Simon A, Guasch-Jimenez M, Guisado-Alonso D, Ramos-Pachon A, Martinez-Domeno A, Izquierdo A, Marin R, Camps-Renom P, Marti-Fabregas J, Fernandez-Cadenas I. Ischaemic stroke patients present sex differences in gut microbiota. Eur J Neurol. 2023 Nov;30(11):3497-3506. doi: 10.1111/ene.15931. Epub 2023 Jul 1.
PubMed 37329328
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Metagenomics and Transcriptomics With the Appearance and Evolution of an Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04795687
- Acronym / sponsor ID
- MAESTRO / IIBSP-MAE-2020-12
- Conditions
- Ischemic Stroke
- Keywords
- Gut microbiota, Stroke, Metagenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke patients | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with ischemic stroke (demonstrated by resonance or head CT).
Key exclusion criteria (2 listed)
- Patients under 18 years of age.
- Additional serious illness or unstable medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of stroke and disability after a stroke
Time frame: 3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 40686474Lledos 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.
- Derived from this study: PubMed 37329328Lledos M, Prats-Sanchez L, Llucia-Carol L, Carcel-Marquez J, Muino E, Cullell N, Gallego-Fabrega C, Martin-Campos JM, Aguilera-Simon A, Guasch-Jimenez M, Guisado-Alonso D, Ramos-Pachon A, Martinez-Domeno A, Izquierdo A, Marin R, Camps-Renom P, Marti-Fabregas J, Fernandez-Cadenas I. Ischaemic stroke patients present sex differences in gut microbiota. Eur J Neurol. 2023 Nov;30(11):3497-3506. doi: 10.1111/ene.15931. Epub 2023 Jul 1.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Fernández Cadenas, PhD principal investigator
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miquel Lledós, MSc (+34679815196, mlledos@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of stroke and disability after a stroke (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021; AzTrials last refreshed its copy on 1 Nov 2026.