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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Charite University, Berlin, Germany
Sponsor:
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
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02008604
First received: November 15, 2013
Last updated: May 28, 2014
Last verified: May 2014

November 15, 2013
May 28, 2014
May 2014
May 2015   (final data collection date for primary outcome measure)
composition of intestinal microbiome [ Time Frame: change between day 1, day 4, day 7, day 14 after stroke ] [ Designated as safety issue: No ]
The composition of the intestinal metagenome / microbiome will be determined by analyzing the 16S rRNA by 454 Pyrosequencing.
Same as current
Complete list of historical versions of study NCT02008604 on ClinicalTrials.gov Archive Site
test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR) [ Time Frame: days 1, 4, 7 after stroke ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Influence of Stroke on the Composition of Intestinal Microbiota
Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Stool samples, Blood samples

Non-Probability Sample

patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital

  • Stroke
  • Transient Ischemic Attack (TIA)
Not Provided
  • Stroke patients
  • TIA patients
    patients with a transient ischemic attack (control group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age: 18 and older
  • ischemic cerebral infarction within the last 36 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
Both
18 Years and older
No
Contact: Andreas Meisel, Prof. Dr. 0049-30-450-660020 andreas.meisel@charite.de
Contact: Katarzyna Winek katarzyna.winek@charite.de
Germany
 
NCT02008604
GUTSTROKE
No
Andreas Meisel, Charite University, Berlin, Germany
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
Principal Investigator: Andreas Meisel, Prof. Dr. Charite University, Berlin, Germany
Charite University, Berlin, Germany
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP