Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.

Detailed Description
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This study aims to detect the impact of probiotics administration during the process of ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the stroke patients.

Official Title
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The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke

Conditions
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Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1. the time from paroxysm to admission ≤2weeks. Exclusion Criteria: Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing vision and reading Illiteracy Have recognitive disorder before stroke (recorded in medical records) Treated with antibiotics probiotics or prebiotics in1month before admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br>the patients in this arm will not receive probiotics. | |
| Experimental: Experimental<br>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months. | Dietary Supplement: Probiotics<br>* the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus,Bifidobacterium lactobacillus,Lactobacillus paracasei,Lactobacillus rhamnosus and Lactobacillus fermentium with does of 8*10^9 Colony-Forming Units(CFU) *2/d for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from admission on gut microbiome at 3months by genome sequencing | change of the gut microbiome will be calculated at 3months in comparison with admission. | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from admission on cognitive function at 3months by Montreal Cognitive Assessment. | change from admission on cognitive function at 3months by Montreal Cognitive Assessment (MoCA). MoCA's score is from 0 to 30.the score is lower,the cognitive disorder is worse. | 3months | 
| change from admission on emotion at 3months by Hamilton Depression Scale. | change from admission on emotion at 3months by Hamilton Depression Scale（HAMD） .When HAMD's score is beyond 17,the patient is considered to have minor depression.When HAMD's score is beyond 20,the patient is considered to have medium depression. When HAMD's score is beyond 30,the patient is considered to have severe depression. | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Gut microbiota, ischemic stroke