Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke

July 29, 2021 updated by: Nanfang Hospital of Southern Medical University

Predictive Value of Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke: A Multiple Center Cohort Study

Post-stroke cognitive impairment(PSCI) is one of the most important factors causing disabilities after stroke. Recent study found that gut microbiota plays a key role in neurological diseases. Two recent small sample studies reported gut dysbiosis in PSCI patients. In order to further verify the relationship between PSCI and gut microbiota and the predictive value of gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke. The study intended to collect stool specimens of patients with acute ischemic stroke and assess their cognitive psychological state, and to establish a prospective multi-center follow-up cohort to explore the correlation between the dynamic changes of intestinal flora in patients with stroke and PSCI and poor prognosis of stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhang Mingsi, Master
  • Phone Number: +86 13827003570
  • Email: meens19@qq.com

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510515
        • Recruiting
        • Department of Neurology, Nanfang Hospital, Southern Medical University
        • Contact:
        • Contact:
          • Zhang Mingsi
          • Phone Number: +8613827003570
          • Email: meens@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic stroke within 7 days of onset

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for acute ischemic stroke;
  • Aged between 18-75;
  • Onset within 7 days;
  • Sign informed consent and agree to provide relevant medical history data and biological specimens.

Exclusion Criteria:

  • Patients diagnosed with TIA
  • Severe disturbance of consciousness (NIHSS consciousness score > 1)
  • Previous severe mental disorders and dementia (AD8 score ≥ 2)
  • History of cerebral hemorrhage or any stroke within 12 months;
  • Serious systemic diseases including malignant tumors
  • Patients with aphasia and unable to cooperate to complete the Montreal Cognitive Assessment (MoCA)
  • ALT or AST greater than 2 times the upper limit of normal value or severe liver disease;
  • GFR less than 30mL/min/1.72m2 or severe kidney disease
  • Alcohol abused, drug use and chemical poisoning history (such as pesticide poisoning)
  • Patients with previous history of gastrointestinal tract or confirmed during hospitalization
  • Patients who could not collect stool samples within 4 days after admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ischemic stroke
Patients with ischemic stroke within 7 days of onset

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination
Time Frame: 7 days after admission
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
7 days after admission
Mini-Mental State Examination
Time Frame: 3 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
3 months after discharge
Mini-Mental State Examination
Time Frame: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
6 months after discharge
Montreal Cognitive Assessment
Time Frame: 7 days after admission
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
7 days after admission
Montreal Cognitive Assessment
Time Frame: 3 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
3 months after discharge
Montreal Cognitive Assessment
Time Frame: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
6 months after discharge
Gut microbiota
Time Frame: 2 days after admission
Results of fecal bacteria by 16s RNA sequencing
2 days after admission
Gut microbiota
Time Frame: 3 months after discharge
Results of fecal bacteria by 16s RNA sequencing
3 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale(mRS)
Time Frame: 7 days after admission
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
7 days after admission
Modified Rankin Scale(mRS)
Time Frame: 3 months after discharge
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
3 months after discharge
Modified Rankin Scale(mRS)
Time Frame: 6 months after discharge
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
6 months after discharge
Modified Rankin Scale(mRS)
Time Frame: 12 months after discharge
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
12 months after discharge
National Institute of Health stroke scale(NIHSS)
Time Frame: Day 1 of admission
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Day 1 of admission
National Institute of Health stroke scale(NIHSS)
Time Frame: Day 7 of admission
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Day 7 of admission
National Institute of Health stroke scale(NIHSS)
Time Frame: 3 months after discharge
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
3 months after discharge
National Institute of Health stroke scale(NIHSS)
Time Frame: 6 months after discharge
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
6 months after discharge
Short chain fatty acids
Time Frame: 2 days after admission
A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique
2 days after admission
Short chain fatty acids
Time Frame: 3 months after discharge
A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique
3 months after discharge
Trimethylamine-N-Oxide
Time Frame: 2 days after admission
A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
2 days after admission
Trimethylamine-N-Oxide
Time Frame: 3 months after discharge
A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
3 months after discharge
Untargeted Metabolomics
Time Frame: 2 days after admission
Untargeted metabolomics refers to using gas chromatography-mass spectrometry (GC-MS) combined technique, without bias detection of all small molecule metabolites in plasma (mainly the relative molecular weight of 1000 Da endogenous small molecule compounds) levels.
2 days after admission
Untargeted Metabolomics
Time Frame: 3 months after discharge
Untargeted metabolomics refers to using gas chromatography-mass spectrometry (GC-MS) combined technique, without bias detection of all small molecule metabolites in plasma (mainly the relative molecular weight of 1000 Da endogenous small molecule compounds) levels.
3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhujiang Hospital
First Affiliated Hospital of Jinan University
Guangdong 999 Brain Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2020-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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