Gastrointestinal Microbiome Clinical Trial
Official title:
The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai 10th People's Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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