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

NCT ID: NCT04688138

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ischemic stroke

Patients with ischemic stroke within 7 days of onset

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong 999 Brain Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology, NanFang Hospital, Southern Medical University

Guanzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yin Jia, Master

Role: CONTACT

+86 13802964883

Zhang Mingsi, Master

Role: CONTACT

+86 13827003570

Facility Contacts

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Yin Jia, master's degree

Role: primary

+8613802964883

Zhang Mingsi

Role: backup

+8613827003570

References

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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.

Reference Type DERIVED
PMID: 37875813 (View on PubMed)

Other Identifiers

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NFEC-2020-169

Identifier Type: -

Identifier Source: org_study_id

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