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
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 2, 2021
June 1, 2021
3.1 years
December 11, 2020
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
7 days after admission
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
3 months after discharge
Mini-Mental State Examination
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
6 months after discharge
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
7 days after admission
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
3 months after discharge
Montreal Cognitive Assessment
A cognitive function screening test ranged 0-30, higher scores mean better cognitive function
6 months after discharge
Gut microbiota
Results of fecal bacteria by 16s RNA sequencing
2 days after admission
Gut microbiota
Results of fecal bacteria by 16s RNA sequencing
3 months after discharge
Secondary Outcomes (14)
Modified Rankin Scale(mRS)
7 days after admission
Modified Rankin Scale(mRS)
3 months after discharge
Modified Rankin Scale(mRS)
6 months after discharge
Modified Rankin Scale(mRS)
12 months after discharge
National Institute of Health stroke scale(NIHSS)
Day 1 of admission
- +9 more secondary outcomes
Study Arms (1)
ischemic stroke
Patients with ischemic stroke within 7 days of onset
Eligibility Criteria
Patients with ischemic stroke within 7 days of onset
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangdong 999 Brain Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- First Affiliated Hospital of Jinan Universitycollaborator
Study Sites (1)
Department of Neurology, NanFang Hospital, Southern Medical University
Guanzhou, Guangdong, 510515, China
Related Publications (1)
Ren 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.
PMID: 37875813DERIVED
Biospecimen
blood plasm; Faeces ;Oral swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 29, 2020
Study Start
June 1, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
August 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share