<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03812445</url>
  </required_header>
  <id_info>
    <org_study_id>cognitionstroke</org_study_id>
    <nct_id>NCT03812445</nct_id>
  </id_info>
  <brief_title>Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke</brief_title>
  <official_title>The Effect of Probiotics on Cognition and Gut Microbiome Associated Study of Shanghai People With Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of&#xD;
      ischemic stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to detect the impact of probiotics administration during the process of&#xD;
      ischemic stroke treatment and recovery phase. The day of admission and 3months after stroke&#xD;
      data will be collected and put into analysis to provide some suggestions on the probiotics&#xD;
      use in the clinical for the stroke patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from admission on gut microbiome at 3months by genome sequencing</measure>
    <time_frame>3months</time_frame>
    <description>change of the gut microbiome will be calculated at 3months in comparison with admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from admission on cognitive function at 3months by Montreal Cognitive Assessment.</measure>
    <time_frame>3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from admission on emotion at 3months by Hamilton Depression Scale.</measure>
    <time_frame>3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Gastrointestinal Microbiome</condition>
  <arm_group>
    <arm_group_label>No Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the patients in this arm will not receive probiotics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <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.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with acute ischemic stroke on the basis of World Health&#xD;
             Organization diagnostic criteria1.&#xD;
&#xD;
        the time from paroxysm to admission ≤2weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Imaging diagnoses hemorrhagic stroke Severe depression Severe disturbance of hearing&#xD;
             vision and reading Illiteracy Have recognitive disorder before stroke (recorded in&#xD;
             medical records) Treated with antibiotics probiotics or prebiotics in1month before&#xD;
             admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huanlong Qin</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yongqiang Liu, postgraduate</last_name>
    <phone>18321785703</phone>
    <email>3101702346@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hao Li, MD</last_name>
    <email>1415701131@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai 10th People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>20072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongqiang Liu, postgraduate</last_name>
      <phone>18321785703</phone>
      <email>3101702346@qq.com</email>
    </contact>
    <investigator>
      <last_name>Huanlong Qin, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 24, 2019</last_update_submitted>
  <last_update_submitted_qc>February 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Huanlong Qin</investigator_full_name>
    <investigator_title>DIRECTOR</investigator_title>
  </responsible_party>
  <keyword>Probiotics</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812445
org study id: cognitionstroke
nct id: NCT03812445
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of
      ischemic stroke patients.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change from admission on gut microbiome at 3months by genome sequencing
time frame: 3months
description: change of the gut microbiome will be calculated at 3months in comparison with admission.
measure: change from admission on cognitive function at 3months by Montreal Cognitive Assessment.
time frame: 3months
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.
measure: change from admission on emotion at 3months by Hamilton Depression Scale.
time frame: 3months
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.
arm group label: No Intervention
arm group type: No Intervention
description: the patients in this arm will not receive probiotics.
arm group label: Experimental
arm group type: Experimental
description: the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus for 3 months.
intervention type: Dietary Supplement
intervention name: Probiotics
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.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Huanlong Qin
role: Study Chair
affiliation: Shanghai 10th People's Hospital
last name: Yongqiang Liu, postgraduate
phone: 18321785703
email: 3101702346@qq.com
last name: Hao Li, MD
email: 1415701131@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Huanlong Qin
investigator title: DIRECTOR
mesh term: Ischemic Stroke