A Study of the Relationship of Gut Microbial Composition and Stroke Outcome

Ischemic Stroke Clinical Trial

— GEMSTONE  

Official title:

A Study of the Relationship of Gut Microbial Composition and Stroke Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03470506
• Other study ID #: 20154
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2019
• Source: University of Virginia
• Contact: Sonya A Gunter, MS
• Phone: 434-924-9664
• Email: sag7bf[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the relationship between gut microbiome (bacteria in the gut), inflammation and the injured brain. It has been established that bacteria in the gut play key roles in digestion, nutrition absorption and immune response of the entire body. Human intestinal bacteria composition in the gut has been associated with several stroke risk factors including obesity, insulin resistance, diabetes and hypertension. If we can establish a relationship between gastrointestinal microbial community composition and ischemic stroke outcomes could lead to dietary interventions in the future to improve recovery after a stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women at least 18 years of age.

2. Willing and able to attend all study visits.

3. English speaking.

4. Must have had a stroke that occurred within 48 hours of admission to the Stroke Unit as determined by a neurologist.

Exclusion Criteria:

1. History of inflammatory bowel disease.

2. Receiving antibiotics within 30 days of entry into the study.

3. History of institutionalization for mental illness within the last year.

4. Unable to consent and does not have a surrogate available to consent on their behalf.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Other:
• Stool Samples
Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Inova Health System	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome	The primary outcome in this case-comparison design of those with excellent vs. non-excellent ischemic stroke outcomes at 3 months as measured by the National Institutes of Health Stroke Scale (NIHSS) is the taxonomic make up of the gut microbial composition. In other words, comprehensive microbiota survey results from 16S rRNA gene sequencing from individuals with excellent outcomes versus all other outcomes at 3 months are the outcome.	Baseline, 3 months
Secondary	Cogstate cognitive correlates and post-stroke microbial composition	Descriptive analyses will be used to develop a preliminary understanding of microbiome composition in relation to measures of cognitive functioning as derived from Cogstate cognitive assessment results at baseline and 3 months post- ischemic stroke	Baseline, 3 months