Status:
COMPLETED
Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
University of Luxembourg
Conditions:
Ischemic Stroke
Transient Ischemic Attack
Eligibility:
All Genders
50+ years
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 characte...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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)
- Hemorrhagic Stroke or intracranial bleeding
- Cerebellar lesions
- Other neurodegenerative diseases (i.e. Parkinson´s Disease or Alzheimers Dementia)
Key Trial Info
Start Date :
June 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04315922
Start Date
June 16 2019
End Date
June 1 2023
Last Update
October 15 2024
Active Locations (1)
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1
LMU University hospital, Munich
Munich, Bavaria, Germany, 81377