Influence of Stroke on the Composition of Intestinal Microbiota

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02008604

Acronym

GUTSTROKE

Enrollment

Registered

2013-12-11

Start date

2014-06-30

Completion date

2018-04-30

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Transient Ischemic Attack (TIA)

Keywords

ischemia, stroke, transient ischemic attack (TIA), microbiome, microbiota, gut

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
composition of intestinal microbiome	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

Measure	Time frame	Description
test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)	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).

Countries

Germany

Outcome results