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

NCT ID: NCT03812445

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Intervention

the patients in this arm will not receive probiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huanlong Qin

DIRECTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huanlong Qin

Role: STUDY_CHAIR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongqiang Liu, postgraduate

Role: CONTACT

18321785703

Hao Li, MD

Role: CONTACT

Facility Contacts

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Yongqiang Liu, postgraduate

Role: primary

18321785703

Other Identifiers

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cognitionstroke

Identifier Type: -

Identifier Source: org_study_id

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