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

February 24, 2019 updated by: Huanlong Qin, Shanghai 10th People's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yongqiang Liu, postgraduate
  • Phone Number: 18321785703
  • Email: 3101702346@qq.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 20072
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No Intervention
the patients in this arm will not receive probiotics.
EXPERIMENTAL: Experimental
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
Time Frame: 3months
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
change from admission on emotion at 3months by Hamilton Depression Scale.
Time Frame: 3months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Study Chair: Huanlong Qin, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

November 30, 2019

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 20, 2019

First Posted (ACTUAL)

January 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cognitionstroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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