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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688138
• Other study ID #: NFEC-2020-169
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Yin Jia, Master
• Phone: +86 13802964883
• Email: jiajiayin[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Department of Neurology, NanFang Hospital, Southern Medical University	Guanzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	First Affiliated Hospital of Jinan University, Guangdong 999 Brain Hospital, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	7 days after admission
Primary	Mini-Mental State Examination	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	3 months after discharge
Primary	Mini-Mental State Examination	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	6 months after discharge
Primary	Montreal Cognitive Assessment	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	7 days after admission
Primary	Montreal Cognitive Assessment	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	3 months after discharge
Primary	Montreal Cognitive Assessment	A cognitive function screening test ranged 0-30, higher scores mean better cognitive function	6 months after discharge
Primary	Gut microbiota	Results of fecal bacteria by 16s RNA sequencing	2 days after admission
Primary	Gut microbiota	Results of fecal bacteria by 16s RNA sequencing	3 months after discharge
Secondary	Modified Rankin Scale(mRS)	A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome	7 days after admission
Secondary	Modified Rankin Scale(mRS)	A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome	3 months after discharge
Secondary	Modified Rankin Scale(mRS)	A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome	6 months after discharge
Secondary	Modified Rankin Scale(mRS)	A neurological function score scale ranged 0-6, higher scores mean worse neurological outcome	12 months after discharge
Secondary	National Institute of Health stroke scale(NIHSS)	Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit	Day 1 of admission
Secondary	National Institute of Health stroke scale(NIHSS)	Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit	Day 7 of admission
Secondary	National Institute of Health stroke scale(NIHSS)	Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit	3 months after discharge
Secondary	National Institute of Health stroke scale(NIHSS)	Neurological function score scale, ranged 0-42, higher scores mean more severe neurological deficit	6 months after discharge
Secondary	Short chain fatty acids	A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique	2 days after admission
Secondary	Short chain fatty acids	A metabolites of gut microbiota from stool, detected by gas chromatography-mass spectrometry (GC-MS) combined technique	3 months after discharge
Secondary	Trimethylamine-N-Oxide	A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry	2 days after admission
Secondary	Trimethylamine-N-Oxide	A metabolites of gut microbiota in plasm, quantified by stable isotope dilution liquid chromatography tandem mass spectrometry	3 months after discharge
Secondary	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.	2 days after admission
Secondary	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.	3 months after discharge