An observational study in Ischemic Stroke and Transient Ischemic Attack, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Ludwig-Maximilians - University of Munich · Observational
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 10 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are recruited and samples taken within 7 days of either stroke or TIA onset.
For the severe stroke cohort, eligibility is defined by:
For the mild stroke cohort, eligibility is defined by:
For the TIA cohort, eligibility is defined by:
Exclusion Criteria:
Severe Stroke as defined by inclusion criteria
Diagnostic Test: Microbiome and Plasma Characterisation
Mild Stroke as defined by inclusion criteria
Diagnostic Test: Microbiome and Plasma Characterisation
Transient Ischemic Attack as defined by inclusion criteria
Diagnostic Test: Microbiome and Plasma Characterisation
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA
Gut Microbiome Composition is assessed using Shotgun Sequencing
Time frame: 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
Time frame: 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
Time frame: 1-7 Days and 90 Days after Stroke
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
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich