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Clinical Trials/NCT03812445
NCT03812445
Unknown
Not Applicable

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

Shanghai 10th People's Hospital1 site in 1 country60 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Microbiome
Sponsor
Shanghai 10th People's Hospital
Enrollment
60
Locations
1
Primary Endpoint
change from admission on gut microbiome at 3months by genome sequencing
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Huanlong Qin

DIRECTOR

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • patients diagnosed with acute ischemic stroke on the basis of World Health Organization diagnostic criteria
  • 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

Outcomes

Primary Outcomes

change from admission on gut microbiome at 3months by genome sequencing

Time Frame: 3months

change of the gut microbiome will be calculated at 3months in comparison with admission.

Secondary Outcomes

  • 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 Sites (1)

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