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

Not Applicable

• Conditions: Gastrointestinal Microbiome
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT03812445
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Probiotics	the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.

Primary Outcome Measures

Name	Time	Method
change from admission on gut microbiome at 3months by genome sequencing	3months	change of the gut microbiome will be calculated at 3months in comparison with admission.

Secondary Outcome Measures

Name	Time	Method
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.	3months	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.
change from admission on emotion at 3months by Hamilton Depression Scale.	3months	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.

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, China