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

Primary Purpose

Gastrointestinal Microbiome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Microbiome focused on measuring Probiotics, Gut microbiota, ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai 10th People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intervention

Experimental

Arm Description

the patients in this arm will not receive probiotics.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 3, 2019
Last Updated
February 24, 2019
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03812445
Brief Title
Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
Official Title
The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Microbiome
Keywords
Probiotics, Gut microbiota, ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
the patients in this arm will not receive probiotics.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from admission on gut microbiome at 3months by genome sequencing
Description
change of the gut microbiome will be calculated at 3months in comparison with admission.
Time Frame
3months
Secondary Outcome Measure Information:
Title
change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
Description
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.
Time Frame
3months
Title
change from admission on emotion at 3months by Hamilton Depression Scale.
Description
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.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqiang Liu, postgraduate
Phone
18321785703
Email
3101702346@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Li, MD
Email
1415701131@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huanlong Qin
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
ZIP/Postal Code
20072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqiang Liu, postgraduate
Phone
18321785703
Email
3101702346@qq.com
First Name & Middle Initial & Last Name & Degree
Huanlong Qin, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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