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

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ClinicalTrials.gov Identifier: NCT03470506
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment
Ischemic Stroke Other: Stool Samples

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : January 6, 2022
Estimated Study Completion Date : July 1, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Fecal and blood samples will be collected. The biorepository will contain acute and convalescent samples: DNA (genetic and epigenetic), RNA (gene expression), serum/plasma (biomarker levels, proteomics), and fecal (microbiome) samples couple with clinical and research data.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470506


Contacts
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Contact: Sonya A Gunter, MS 434-924-9664 sag7bf@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Enrolling by invitation
Charlottesville, Virginia, United States, 22908
Inova Health System Recruiting
Fairfax, Virginia, United States, 22031
Contact: Robert Lipsky, PhD    571-472-0240    robert.lipsky@inova.org   
Sponsors and Collaborators
University of Virginia
University of Colorado, Denver
Investigators
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Principal Investigator: Bradford Worrall, MD, MS University of Virginia
More Information
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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT03470506    
Other Study ID Numbers: 20154
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases