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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04688138
Enrollment
600
Registered
2020-12-29
Start date
2020-06-01
Completion date
2023-06-30
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; cognitive impairment; gut microbiota

Brief 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. 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.

Interventions

None listed

Sponsors

Guangdong 999 Brain Hospital
CollaboratorOTHER
Zhujiang Hospital
CollaboratorOTHER
First Affiliated Hospital of Jinan University
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Mini-Mental State Examination7 days after admissionA cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Montreal Cognitive Assessment7 days after admissionA cognitive function screening test ranged 0-30, higher scores mean better cognitive function
Gut microbiota2 days after admissionResults of fecal bacteria by 16s RNA sequencing

Secondary

MeasureTime frameDescription
Trimethylamine-N-Oxide2 days after admissionA metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry
Modified Rankin Scale(mRS)7 days after admissionA neurological function score scale ranged 0-6, higher scores mean worse neurological outcome
Untargeted Metabolomics2 days after admissionUntargeted 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.
National Institute of Health stroke scale(NIHSS)Day 1 of admissionNeurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit
Short chain fatty acids2 days after admissionA metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique

Countries

China

Contacts

Primary ContactYin Jia, Master
jiajiayin@139.com+86 13802964883
Backup ContactZhang Mingsi, Master
meens19@qq.com+86 13827003570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026