SMB: Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Severe Ischemic Stroke Severe Stroke as defined by inclusion criteria |
Diagnostic Test: Microbiome and Plasma Characterisation
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
|
| Mild Ischemic Stroke Mild Stroke as defined by inclusion criteria |
Diagnostic Test: Microbiome and Plasma Characterisation
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
|
| Transient Ischemic Attack Transient Ischemic Attack as defined by inclusion criteria |
Diagnostic Test: Microbiome and Plasma Characterisation
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
|
Outcome Measures
Primary Outcome Measures
- Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA [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 [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 [1-7 Days and 90 Days after Stroke]
Immune Populations are measured using Flow Cytometry
Secondary Outcome Measures
- National Institute of Health Stroke Scale (NIHSS) [1-7 days and 90 days after stroke]
- Modified Rankin Score (mRS) [1-7 days and 90 days after stroke]
- CT and (if available) MRI documentation [1-7 days and 90 days after stroke]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written consent as submitted and approved to the human subjects review board must be gathered from the participants
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Participants must be at least 50 years of age
For the severe stroke cohort, eligibility is defined by:
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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
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Ischemic Stroke occured within the last 7 days
For the mild stroke cohort, eligibility is defined by:
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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
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Ischemic Stroke occured within the last 7 days
For the TIA cohort, eligibility is defined by:
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CT or MRI confirmed absence of a lesion
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NIHSS of 0 no more than 24 hours after induction into emergency room
-
TIA occured within the last 7 days
Exclusion Criteria:
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Pregnancy
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Diagnosed and malignant Tumor ailment
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Active, non-stroke related immunosuppression (i.e. HIV)
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Infection, operative procedure or antibiotics treatment within 4 weeks prior to stroke/TIA
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Relevant autoimmune disease (i.e Morbus Crohn)
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Chronic infectious diseases (i.e Hepatitis C)
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Hemorrhagic Stroke or intracranial bleeding
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Cerebellar lesions
-
Other neurodegenerative diseases (i.e. Parkinson´s Disease or Alzheimers Dementia)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum der Universität München - Standort Großhadern | Munich | Bavaria | Germany | 81377 |
Sponsors and Collaborators
- Ludwig-Maximilians - University of Munich
- University of Luxembourg
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Synergy ID 390857198 SMB