Ischemic StrokeNCT04688138
Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke
An observational study of Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 30 Jun 2023
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with ischemic stroke within 7 days of onset
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, NanFang Hospital, Southern Medical University
Guanzhou, Guangdong, 510515
Yin Jia, master's degree, +8613802964883, jiajiayin@139.com
Zhang Mingsi, +8613827003570, meens@qq.com
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke; cognitive impairment; gut microbiota
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ischemic stroke | Patients with ischemic stroke within 7 days of onset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 7 days after admission
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 3 months after discharge
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 6 months after discharge
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 7 days after admission
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 3 months after discharge
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Measured: 6 months after discharge
Gut microbiota
Results of fecal bacteria by 16s RNA sequencing
Measured: 2 days after admission
Gut microbiota
Results of fecal bacteria by 16s RNA sequencing
Measured: 3 months after discharge
Secondary outcomes (14)
Modified Rankin Scale(mRS)
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Measured: 7 days after admission
Modified Rankin Scale(mRS)
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Measured: 3 months after discharge
Modified Rankin Scale(mRS)
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Measured: 6 months after discharge
Modified Rankin Scale(mRS)
A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Measured: 12 months after discharge
National Institute of Health stroke scale(NIHSS)
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Measured: Day 1 of admission
National Institute of Health stroke scale(NIHSS)
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Measured: Day 7 of admission
National Institute of Health stroke scale(NIHSS)
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Measured: 3 months after discharge
National Institute of Health stroke scale(NIHSS)
Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Measured: 6 months after discharge
Short chain fatty acids
A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique
Measured: 2 days after admission
Short chain fatty acids
A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique
Measured: 3 months after discharge
Trimethylamine-N-Oxide
A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
Measured: 2 days after admission
Trimethylamine-N-Oxide
A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
Measured: 3 months after discharge
Untargeted Metabolomics
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.
Measured: 2 days after admission
Untargeted Metabolomics
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.
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong 999 Brain Hospital, Zhujiang Hospital, First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688138
- Sponsor's protocol ID
- NFEC-2020-169
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie J, Ren Y, Lai M, Liang J, Liang J, Zheng Y, Wang H, Zhang J, Zhao B, Song W, Yin J. Gut microbiota rescues vascular cognitive impairment by improving glymphatic function via the ILA-AHR-AQP4 pathway. Pharmacol Res. 2026 Sep 25;233:109646. doi: 10.1016/j.phrs.2026.109646. Online ahead of print.
PubMed 42790831Ren Y, Liang J, Li X, Deng Y, Cheng S, Wu Q, Song W, He Y, Zhu J, Zhang X, Zhou H, Yin J. Association between oral microbial dysbiosis and poor functional outcomes in stroke-associated pneumonia patients. BMC Microbiol. 2023 Oct 24;23(1):305. doi: 10.1186/s12866-023-03057-8.
PubMed 37875813
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke: A Multiple Center Cohort Study
- ClinicalTrials.gov ID
- NCT04688138
- Acronym / sponsor ID
- NFEC-2020-169
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke; cognitive impairment; gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangdong 999 Brain Hospital, Zhujiang Hospital, First Affiliated Hospital of Jinan University
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Dec 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke | – | –Patients with ischemic stroke within 7 days of onset |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke within 7 days of onset
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental State Examination
Time frame: 7 days after admission
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Mini-Mental State Examination
Time frame: 3 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Mini-Mental State Examination
Time frame: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment
Time frame: 7 days after admission
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment
Time frame: 3 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment
Time frame: 6 months after discharge
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Gut microbiota
Time frame: 2 days after admission
Results of fecal bacteria by 16s RNA sequencing
Gut microbiota
Time frame: 3 months after discharge
Results of fecal bacteria by 16s RNA sequencing
14 secondary outcomes
Modified Rankin Scale(mRS)
Time frame: 7 days after admission
Modified Rankin Scale(mRS)
Time frame: 3 months after discharge
Modified Rankin Scale(mRS)
Time frame: 6 months after discharge
Modified Rankin Scale(mRS)
Time frame: 12 months after discharge
National Institute of Health stroke scale(NIHSS)
Time frame: Day 1 of admission
National Institute of Health stroke scale(NIHSS)
Time frame: Day 7 of admission
National Institute of Health stroke scale(NIHSS)
Time frame: 3 months after discharge
National Institute of Health stroke scale(NIHSS)
Time frame: 6 months after discharge
Short chain fatty acids
Time frame: 2 days after admission
Short chain fatty acids
Time frame: 3 months after discharge
Trimethylamine-N-Oxide
Time frame: 2 days after admission
Trimethylamine-N-Oxide
Time frame: 3 months after discharge
Untargeted Metabolomics
Time frame: 2 days after admission
Untargeted Metabolomics
Time frame: 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 42790831Xie J, Ren Y, Lai M, Liang J, Liang J, Zheng Y, Wang H, Zhang J, Zhao B, Song W, Yin J. Gut microbiota rescues vascular cognitive impairment by improving glymphatic function via the ILA-AHR-AQP4 pathway. Pharmacol Res. 2026 Sep 25;233:109646. doi: 10.1016/j.phrs.2026.109646. Online ahead of print.
- Derived from this study: PubMed 37875813Ren Y, Liang J, Li X, Deng Y, Cheng S, Wu Q, Song W, He Y, Zhu J, Zhang X, Zhou H, Yin J. Association between oral microbial dysbiosis and poor functional outcomes in stroke-associated pneumonia patients. BMC Microbiol. 2023 Oct 24;23(1):305. doi: 10.1186/s12866-023-03057-8.
- Individual participant dataSharing planned: No
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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.
1 site 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 Nanfang Hospital, Southern Medical University at 1 site in China.
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 11 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Yin Jia, Master (+86 13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: 7 days after admission). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688138, which also lists 2 linked publications.
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 2 Aug 2021.