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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03812445
Other study ID # cognitionstroke
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date December 30, 2019

Study information

Verified date February 2019
Source Shanghai 10th People's Hospital
Contact Yongqiang Liu, postgraduate
Phone 18321785703
Email 3101702346@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotics
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.

Locations

Country Name City State
China Shanghai 10th People's Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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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