A Study of the Relationship of Gut Microbial Composition and Stroke Outcome (GEMSTONE)

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: Stool Samples

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Sonya A Gunter, MS; Phone Number: 434-924-9664; Email: sag7bf@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Enrolling by invitation
      • University of Virginia Health System
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Inova Health System
      • Contact: Robert Lipsky, PhD; Phone Number: 571-472-0240; Email: robert.lipsky@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ischemic stroke; Diagnosed with an ischemic stroke by a Neurologist	Other: Stool Samples; Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Bradford Worrall, MD, MS, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): January 6, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 20154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No