Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT03470506

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stool Samples

Study Details

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.

Conditions

Ischemic Stroke

Study ID

NCT03470506

Start date

Feb 20, 2018

Status verified date

Nov, 2019

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Jan 6, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Ischemic stroke

Diagnosed with an ischemic stroke by a Neurologist

Interventions

Stool Samples

Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sonya A Gunter, MS

434-924-9664sag7bf@hscmail.mcc.virginia.edu

Locations

Inova Health System

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Robert Lipsky, PhD

571-472-0240robert.lipsky@inova.org

More Information

Sponsor

University of Virginia

Last update posted

Nov 19, 2019

Last verified

Nov, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2019-11-19.