Ischemic StrokeSMBNCT04315922
Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)
An observational study of Ischemic Stroke and Transient Ischemic Attack, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Preclinical research has established a convincing connection between changes in the gut microbiota composition and stroke outcome. However clinical data on the gut-brain axis, and its chronic characteristics, is sparse. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Microbiome and Plasma Characterisation
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2019to 1 Jun 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are recruited and samples taken within 7 days of either stroke or TIA onset.
Who may be able to join
- Written consent as submitted and approved to the human subjects review board must be gathered from the participants
- Participants must be at least 50 years of age
- For the severe stroke cohort, eligibility is defined by:
- CT or MRI confirmed ischemic stroke affecting at least 1/3 of the anterior, medial or posterior cerebral arteries cortical coverage
- NIHSS of at least 10 at time of induction into emergency room
- Ischemic Stroke occured within the last 7 days
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- For the mild stroke cohort, eligibility is defined by:
- CT or MRI confirmed ischemic stroke affecting no more than 1/3 of the anterior, medial or posterior cerebral arteries cortical coverage
- NIHSS between 1 and 10 at time of induction into emergency room
- Ischemic Stroke occured within the last 7 days
- For the TIA cohort, eligibility is defined by:
- CT or MRI confirmed absence of a lesion
- NIHSS of 0 no more than 24 hours after induction into emergency room
- TIA occured within the last 7 days
Who cannot join
- Pregnancy
- Diagnosed and malignant Tumor ailment
- Active, non-stroke related immunosuppression (i.e. HIV)
- Infection, operative procedure or antibiotics treatment within 4 weeks prior to stroke/TIA
- Relevant autoimmune disease (i.e Morbus Crohn)
- Chronic infectious diseases (i.e Hepatitis C)
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- Hemorrhagic Stroke or intracranial bleeding
- Cerebellar lesions
- Other neurodegenerative diseases (i.e. Parkinson´s Disease or Alzheimers Dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Preclinical research has established a convincing connection between changes in the gut microbiota composition and stroke outcome. However clinical data on the gut-brain axis, and its chronic characteristics, is sparse. Additional investigations in the context of ischemic stroke regarding the relationship between dysbiosis and functional changes of the microbiome, as characterized by the metabolome, are still required. The StrokeMicroBiomics study will offer insight into these mechanisms and offer new potential targets for therapeutic interventions.
The primary objective is the characterisation of gut dysbiosis in ischemic stroke patients in the acute phase after stroke and during a 3 month follow-up period.
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
Read the detailed description
Results of experimental, preclinical studies suggest that microbiome-targeted may improve stroke outcome as well as stroke-related comorbidities. Yet, clinical trials describing the extent and time course of microbiome changes after stroke are currently not available. Moreover, the impact of post-stroke dysbiosis on metabolic changes and the systemic immunity are unexplored.
Therefore, the primary objective of this trial is the characterization of gut dysbiosis progression in ischemic stroke patients during a 3 month follow-up period .
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
In order to elucidate the differential impact of lesion size on immune and microbiome homeostasis, separate patient cohorts with mild and severe stroke will be studied.
Furthermore, to control for the effects of temporary focal neurological deficits and stress induced microbiome and immune changes, patients with stroke mimics and transient ischemic attacks (TIA) are being recruited to the control group.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- Microbiome and Plasma Characterisation
- Keywords
- Microbiome, Immune System, Metabolome, Brain Lesion, Gut-Brain Axis
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome and Plasma CharacterisationDiagnostic test
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
| Study group | Role | What they receive |
|---|---|---|
| Severe Ischemic Stroke | Severe Stroke as defined by inclusion criteria Receives: Diagnostic Test: Microbiome and Plasma Characterisation | |
| Mild Ischemic Stroke | Mild Stroke as defined by inclusion criteria Receives: Diagnostic Test: Microbiome and Plasma Characterisation | |
| Transient Ischemic Attack | Transient Ischemic Attack as defined by inclusion criteria Receives: Diagnostic Test: Microbiome and Plasma Characterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA
Gut Microbiome Composition is assessed using Shotgun Sequencing
Measured: 1-7 Days and 90 Days after Stroke
Changes from Baseline of the Gut Metabolome as measured in Blood and Stool at 3 Months post Stroke/TIA
The Metabolome is measured using Mass-Spectometry
Measured: 1-7 Days and 90 Days after Stroke
Changes from Baseline in key Immune Populations at 3 Months post Stroke/TIA
Immune Populations are measured using Flow Cytometry
Measured: 1-7 Days and 90 Days after Stroke
Secondary outcomes (3)
National Institute of Health Stroke Scale (NIHSS)
Measured: 1-7 days and 90 days after stroke
Modified Rankin Score (mRS)
Measured: 1-7 days and 90 days after stroke
CT and (if available) MRI documentation
Measured: 1-7 days and 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start16 Jun 2019
- Primary completion1 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luxembourg
- Responsible party
- Principal investigator, Philip William Melton, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315922
- Sponsor's protocol ID
- Synergy ID 390857198 SMB
- Acronym
- SMB
- Status last verified
- Oct 2024
- First submitted
- 12 Mar 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)
- ClinicalTrials.gov ID
- NCT04315922
- Acronym / sponsor ID
- SMB / Synergy ID 390857198 SMB
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Microbiome, Immune System, Metabolome, Brain Lesion, Gut-Brain Axis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- University of Luxembourg
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Mar 2020 (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.
Preclinical research has established a convincing connection between changes in the gut microbiota composition and stroke outcome. However clinical data on the gut-brain axis, and its chronic characteristics, is sparse. Additional investigations in the context of ischemic stroke regarding the relationship between dysbiosis and functional changes of the microbiome, as characterized by the metabolome, are still required. The StrokeMicroBiomics study will offer insight into these mechanisms and offer new potential targets for therapeutic interventions.
The primary objective is the characterisation of gut dysbiosis in ischemic stroke patients in the acute phase after stroke and during a 3 month follow-up period.
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
Detailed description
Results of experimental, preclinical studies suggest that microbiome-targeted may improve stroke outcome as well as stroke-related comorbidities. Yet, clinical trials describing the extent and time course of microbiome changes after stroke are currently not available. Moreover, the impact of post-stroke dysbiosis on metabolic changes and the systemic immunity are unexplored.
Therefore, the primary objective of this trial is the characterization of gut dysbiosis progression in ischemic stroke patients during a 3 month follow-up period .
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
In order to elucidate the differential impact of lesion size on immune and microbiome homeostasis, separate patient cohorts with mild and severe stroke will be studied.
Furthermore, to control for the effects of temporary focal neurological deficits and stress induced microbiome and immune changes, patients with stroke mimics and transient ischemic attacks (TIA) are being recruited to the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Ischemic Stroke | – | Diagnostic Test: Microbiome and Plasma CharacterisationSevere Stroke as defined by inclusion criteria |
| Mild Ischemic Stroke | – | Diagnostic Test: Microbiome and Plasma CharacterisationMild Stroke as defined by inclusion criteria |
| Transient Ischemic Attack | – | Diagnostic Test: Microbiome and Plasma CharacterisationTransient Ischemic Attack as defined by inclusion criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited and samples taken within 7 days of either stroke or TIA onset.
Key inclusion criteria (14 listed)
- Written consent as submitted and approved to the human subjects review board must be gathered from the participants
- Participants must be at least 50 years of age
- CT or MRI confirmed ischemic stroke affecting at least 1/3 of the anterior, medial or posterior cerebral arteries cortical coverage
- NIHSS of at least 10 at time of induction into emergency room
- Ischemic Stroke occured within the last 7 days
Key exclusion criteria (9 listed)
- Pregnancy
- Diagnosed and malignant Tumor ailment
- Active, non-stroke related immunosuppression (i.e. HIV)
- Infection, operative procedure or antibiotics treatment within 4 weeks prior to stroke/TIA
- Relevant autoimmune disease (i.e Morbus Crohn)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome and Plasma CharacterisationFlow Cytometry, Mass-Spectometry, Shotgun-Sequencing | Diagnostic test | Mild Ischemic Stroke, Severe Ischemic Stroke, Transient Ischemic Attack |
Primary outcome
Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA
Time frame: 1-7 Days and 90 Days after Stroke
Gut Microbiome Composition is assessed using Shotgun Sequencing
Changes from Baseline of the Gut Metabolome as measured in Blood and Stool at 3 Months post Stroke/TIA
Time frame: 1-7 Days and 90 Days after Stroke
The Metabolome is measured using Mass-Spectometry
Changes from Baseline in key Immune Populations at 3 Months post Stroke/TIA
Time frame: 1-7 Days and 90 Days after Stroke
Immune Populations are measured using Flow Cytometry
3 secondary outcomes
National Institute of Health Stroke Scale (NIHSS)
Time frame: 1-7 days and 90 days after stroke
Modified Rankin Score (mRS)
Time frame: 1-7 days and 90 days after stroke
CT and (if available) MRI documentation
Time frame: 1-7 days and 90 days after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Transient Ischemic Attack, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 14 inclusion and 9 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA (time frame: 1-7 Days and 90 Days after Stroke). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.