Influence of Stroke on the Composition of Intestinal Microbiota

NCT ID: NCT02008604

Last Updated: 2018-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-04-30

Brief Summary

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The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.

Detailed Description

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Conditions

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Stroke Transient Ischemic Attack (TIA)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke patients

No interventions assigned to this group

TIA patients

patients with a transient ischemic attack (control group)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age: 18 and older
* ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity
* patient consent or consent by a legal representative
* NIHSS \> or =9 (stroke patients)
* NIHSS \< 1 (for TIA patients)

Exclusion Criteria

* intracranial hemorrhage
* preexisting dysphagia
* signs of infection upon admission (clinical/paraclinical)
* existing antibiotic therapy upon admission or within the last 2 weeks before admission
* mechanical ventilation upon admission
* participation in an interventional therapy study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany

UNKNOWN

Sponsor Role collaborator

Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany

UNKNOWN

Sponsor Role collaborator

PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany

UNKNOWN

Sponsor Role collaborator

NeuroCure Clinical Research Center, Charite, Berlin

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Meisel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Meisel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charite Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GUTSTROKE

Identifier Type: -

Identifier Source: org_study_id

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