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Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)

This study is currently recruiting participants.
Verified June 2017 by Andreas Meisel, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008604
First Posted: December 11, 2013
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany
Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany
PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
  Purpose
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.

Condition
Stroke Transient Ischemic Attack (TIA)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)

Resource links provided by NLM:


Further study details as provided by Andreas Meisel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • composition of intestinal microbiome [ Time Frame: change between day 1, day 4, day 7, day 14 after stroke ]
    The composition of the intestinal metagenome / microbiome will be determined by analyzing the 16S rRNA by 454 Pyrosequencing.


Secondary Outcome Measures:
  • test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR) [ Time Frame: days 1, 4, 7 after stroke ]
    Analysis of correlation between changes in microbiome (most changed group of bacteria, e.g. lactobacilli) with changes in immunological parameters (e.g. HLA-DR, IL-6, IL-10, CD4-lymphocytes from blood samples).


Biospecimen Retention:   Samples With DNA
Stool samples, Blood samples

Estimated Enrollment: 26
Study Start Date: May 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke patients
TIA patients
patients with a transient ischemic attack (control group)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008604


Contacts
Contact: Andreas Meisel, Prof. Dr. 0049-30-450-660020 andreas.meisel@charite.de
Contact: Katarzyna Winek katarzyna.winek@charite.de

Locations
Germany
Charite Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Andreas Meisel, Prof. Dr.    0049 30 450 660026    andreas.meisel@charite.de   
Contact: Katarzyna Winek       katarzyna.winek@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany
Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany
PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, Prof. Dr. Charite University, Berlin, Germany
  More Information

Responsible Party: Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02008604     History of Changes
Other Study ID Numbers: GUTSTROKE
First Submitted: November 15, 2013
First Posted: December 11, 2013
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
ischemia
stroke
transient ischemic attack (TIA)
microbiome
microbiota
gut

Additional relevant MeSH terms:
Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia