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

November 17, 2019 updated by: University of Virginia
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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 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.
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cogstate cognitive correlates and post-stroke microbial composition
Time Frame: 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
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

University of Colorado, Denver

Investigators

  • Principal Investigator: Bradford Worrall, MD, MS, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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