Gastrointestinal Microbiome
Conditions
Keywords
Probiotics, Gut microbiota, ischemic stroke
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
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.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYongqiang Liu, postgraduate
Backup ContactHao Li, MD
Outcome results
None listed