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

Gastrointestinal Microbiome Clinical Trial

Official title:

The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812445
• Other study ID #: cognitionstroke
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

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