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

This study is not yet open for participant recruitment.
Verified December 2013 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: December 6, 2013
Last verified: December 2013
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ 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).


Biospecimen Retention:   Samples With DNA

Stool samples, Blood samples


Estimated Enrollment: 26
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke patients
TIA patients
patients with a transient ischemic attack (control group)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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
Investigators
Principal Investigator: Andreas Meisel, Prof. Dr. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02008604     History of Changes
Other Study ID Numbers: GUTSTROKE
Study First Received: November 15, 2013
Last Updated: December 6, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 17, 2014