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

University of Virginia

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Other: Stool Samples

Study type: Observational

Funder types: Other

Identifiers

NCT03470506

20154

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Ischemic stroke

Description:

Diagnosed with an ischemic stroke by a Neurologist

Treatment:

Other: Stool Samples