NCT03470506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

3.9 years

First QC Date

December 29, 2017

Last Update Submit

November 17, 2019

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Measured differences in taxonomic make-up and the relative frequency of the gut microbial composition in relation to excellent vs. poor stroke outcome

    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.

    Baseline, 3 months

Secondary Outcomes (1)

  • Cogstate cognitive correlates and post-stroke microbial composition

    Baseline, 3 months

Study Arms (1)

Ischemic stroke

Diagnosed with an ischemic stroke by a Neurologist

Other: Stool Samples

Interventions

Stool SamplesOTHER

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

Ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA

You may qualify if:

  • Men and women at least 18 years of age.
  • Willing and able to attend all study visits.
  • English speaking.
  • Must have had a stroke that occurred within 48 hours of admission to the Stroke Unit as determined by a neurologist.

You may not qualify if:

  • History of inflammatory bowel disease.
  • Receiving antibiotics within 30 days of entry into the study.
  • History of institutionalization for mental illness within the last year.
  • Unable to consent and does not have a surrogate available to consent on their behalf.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

ENROLLING BY INVITATION

Inova Health System

Fairfax, Virginia, 22031, United States

RECRUITING

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.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bradford Worrall, MD, MS

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya A Gunter, MS

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2017

First Posted

March 20, 2018

Study Start

February 20, 2018

Primary Completion

January 6, 2022

Study Completion

July 1, 2022

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

US(2)