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

November 28, 2018 updated by: Andreas Meisel, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Stroke patients
TIA patients
patients with a transient ischemic attack (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change between day 1, day 4, day 7, day 14 after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
days 1, 4, 7 after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUTSTROKE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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