Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of ischemic stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFebruary 26, 2019
February 1, 2019
1.5 years
January 3, 2019
February 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
3months
change from admission on emotion at 3months by Hamilton Depression Scale.
3months
Study Arms (2)
No Intervention
NO INTERVENTIONthe patients in this arm will not receive probiotics.
Experimental
EXPERIMENTALthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria1.
- the time from paroxysm to admission ≤2weeks.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai 10th People's Hospital
Shanghai, 20072, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huanlong Qin
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DIRECTOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 23, 2019
Study Start
June 1, 2018
Primary Completion
November 30, 2019
Study Completion
December 30, 2019
Last Updated
February 26, 2019
Record last verified: 2019-02