A Study of the Relationship of Gut Microbial Composition and Stroke Outcome

NCT ID: NCT03470506

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2022-07-01

Brief Summary

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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

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischemic stroke

Diagnosed with an ischemic stroke by a Neurologist

Stool Samples

Intervention Type OTHER

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

Interventions

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Stool Samples

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradford Worrall, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status ENROLLING_BY_INVITATION

Inova Health System

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sonya A Gunter, MS

Role: CONTACT

434-924-9664

Facility Contacts

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Robert Lipsky, PhD

Role: primary

571-472-0240

Other Identifiers

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20154

Identifier Type: -

Identifier Source: org_study_id

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