Influence of Stroke on the Composition of Intestinal Microbiota

Stroke Clinical Trial

— GUTSTROKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008604
• Other study ID #: GUTSTROKE
• Status: Completed
• Start date: June 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack (TIA)

Locations

Country	Name	City	State
Germany	Charite Universitätsmedizin Berlin	Berlin

Sponsors (5)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composition of intestinal microbiome	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	test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)	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