Influence of Stroke on the Composition of Intestinal Microbiota

NCT02008604 | Completed

• 1 other identifier: GUTSTROKE
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Transient Ischemic Attack (TIA)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)

  days 1, 4, 7 after stroke

Study Arms (2)

Stroke patients

TIA patients

patients with a transient ischemic attack (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, Blood samples

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Meisel, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 11, 2013
• Study Start: June 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

DE (1)