Influence of Stroke on the Composition of Intestinal Microbiota

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Ischemic Attack, Transient Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Transient Ischemic Attack (TIA) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany
Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany

Registry information

Official study title

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

Acronym: GUTSTROKE

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Dec 11, 2013
Registry last updated: Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed