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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

Tracking Information
First Submitted Date December 29, 2017
First Posted Date March 20, 2018
Last Update Posted Date November 19, 2019
Actual Study Start Date February 20, 2018
Estimated Primary Completion Date January 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 17, 2019)
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
Original Secondary Outcome Measures
 (submitted: March 16, 2018)
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/TIA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
Official Title A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Probability Sample
Study Population Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA
Condition Ischemic Stroke
Intervention Other: Stool Samples
Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups
Study Groups/Cohorts Ischemic stroke
Diagnosed with an ischemic stroke by a Neurologist
Intervention: Other: Stool Samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 16, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2022
Estimated Primary Completion Date January 6, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sonya A Gunter, MS 434-924-9664 sag7bf@hscmail.mcc.virginia.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03470506
Other Study ID Numbers 20154
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Virginia
Study Sponsor University of Virginia
Collaborators University of Colorado, Denver
Investigators
Principal Investigator: Bradford Worrall, MD, MS University of Virginia
PRS Account University of Virginia
Verification Date November 2019