Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)

NCT04315922 | Completed

• 1 other identifier: Synergy ID 390857198 SMB
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

Microbiome; Immune System; Metabolome; Brain Lesion; Gut-Brain Axis

Outcome Measures

Primary Outcomes (3)

• Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA

  Gut Microbiome Composition is assessed using Shotgun Sequencing

  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

  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

  1-7 Days and 90 Days after Stroke

Secondary Outcomes (3)

• 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

Study Arms (3)

Severe Ischemic Stroke

Severe Stroke as defined by inclusion criteria

Diagnostic Test: Microbiome and Plasma Characterisation

Mild Ischemic Stroke

Mild Stroke as defined by inclusion criteria

Diagnostic Test: Microbiome and Plasma Characterisation

Transient Ischemic Attack

Transient Ischemic Attack as defined by inclusion criteria

Diagnostic Test: Microbiome and Plasma Characterisation

Interventions

Microbiome and Plasma Characterisation DIAGNOSTIC_TEST

Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing

Mild Ischemic Stroke; Severe Ischemic Stroke; Transient Ischemic Attack

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited and samples taken within 7 days of either stroke or TIA onset.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• University of Luxembourg: collaborator

Study Sites (1)

LMU University hospital, Munich

Munich, Bavaria, 81377, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and blood samples collected at both acute and chronic timepoints from study participants are stored at -80°C in on-site Biobank.

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 20, 2020
• Study Start: June 16, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DE (1)