Ischemic StrokeGEMSTONENCT03470506
A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
An observational study of Ischemic Stroke, run by University of Virginia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Stool Samples
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2018to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Enrolling by invitation
University of Virginia Health System
Charlottesville, Virginia, 22908
- Recruiting
Inova Health System
Fairfax, Virginia, 22031
Robert Lipsky, PhD, 571-472-0240, robert.lipsky@inova.org
About this study
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
- Being tested
- Stool Samples
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool SamplesOther
Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke | Diagnosed with an ischemic stroke by a Neurologist Receives: Other: Stool Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (1)
Cogstate cognitive correlates and post-stroke microbial composition
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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start20 Feb 2018
- Primary completion6 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Bradford Worrall, MD, MS, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470506
- Sponsor's protocol ID
- 20154
- Acronym
- GEMSTONE
- Status last verified
- Nov 2019
- First submitted
- 29 Dec 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Relationship of Gut Microbial Composition and Stroke Outcome
- ClinicalTrials.gov ID
- NCT03470506
- Acronym / sponsor ID
- GEMSTONE / 20154
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 6 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | – | Other: Stool SamplesDiagnosed with an ischemic stroke by a Neurologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community probability sample of adults who have suffered an ischemic stroke within 48 hours of admission to UVA
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool SamplesStool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups | Other | Ischemic stroke |
Primary outcome
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.
1 secondary outcome
Cogstate cognitive correlates and post-stroke microbial composition
Time frame: Baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford Worrall, MD, MS principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Virginia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonya A Gunter, MS (434-924-9664, sag7bf@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.