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

• Conditions: Ischemic Stroke
• Interventions: Other: Stool Samples

• Registration Number: NCT03470506
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-29
• Study Start: 2018-02-20
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-17
• Last Update Posted: 2019-11-19
• Primary Completion: 2022-01-06
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ischemic stroke	Stool Samples	Diagnosed with an ischemic stroke by a Neurologist

Primary Outcome Measures

Name	Time	Method
Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome	Baseline, 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Cogstate cognitive correlates and post-stroke microbial composition	Baseline, 3 months	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

Trial Locations

Locations (2)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Inova Health System; 🇺🇸 Fairfax, Virginia, United States