Multiomics Targeting Microbiome Associated Changes in Stroke Patients

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04315922
Study type	Observational
Source	Ludwig-Maximilians - University of Munich
Contact	Philip W Melton
Phone	0176 31271941
Email	philip.melton@med.uni-muenchen.de
Status	Recruiting
Phase
Start date	June 16, 2019
Completion date	March 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics) — SMB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms