Influence of Stroke on the Composition of Intestinal Microbiota

Completed

• Conditions: Stroke; Transient Ischemic Attack (TIA)

• Registration Number: NCT02008604
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Study Start: 2014-06
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany