Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)

Ischemic Stroke Clinical Trial

— SMB  

Official title:

Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04315922
• Other study ID #: Synergy ID 390857198 SMB
• Status: Recruiting
• Start date: June 16, 2019
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: Ludwig-Maximilians - University of Munich
• Contact: Philip W Melton
• Phone: 0176 31271941
• Email: philip.melton[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Diagnostic Test:
• Microbiome and Plasma Characterisation
Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing

Locations

Country	Name	City	State
Germany	Klinikum der Universität München - Standort Großhadern	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	University of Luxembourg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	National Institute of Health Stroke Scale (NIHSS)		1-7 days and 90 days after stroke
Secondary	Modified Rankin Score (mRS)		1-7 days and 90 days after stroke
Secondary	CT and (if available) MRI documentation		1-7 days and 90 days after stroke