<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/NCT03827733</url>
  </required_header>
  <id_info>
    <org_study_id>dsyy004</org_study_id>
    <nct_id>NCT03827733</nct_id>
  </id_info>
  <brief_title>Gut Microbiota and Alzheimer's Diseases</brief_title>
  <official_title>Gut Microbiota and Alzheimer's Diseases</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator will perform clinical studies to test a hypothesis that participants who&#xD;
      have Alzheimer's disease will have different gut/oral microbiota profile as compared to the&#xD;
      participants who do not have Alzheimer's disease. The investigators will also check the&#xD;
      microbiome of their partners in this study. The investigators plan to perform the studies in&#xD;
      150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai&#xD;
      city. Investigators will also measure the beta-amyloid in the feces of the participants.&#xD;
      Finally, the investigators will determine cognitive function in these participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant&#xD;
      impact on the behavior and brain pathology consistent with Alzheimer's disease (AD)&#xD;
      neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome&#xD;
      and feces beta-amyloid of AD patients are different from those of the participants without AD&#xD;
      and their partners. The investigators plan to recruit 150 subjects, including three groups of&#xD;
      normal elders, AD patients and the partners of the AD patients. The cognitive function will&#xD;
      be assessed and the feces and oral samples will be collected to determine whether there are&#xD;
      differences or correlations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gut beta-amyloid 42</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
    <description>Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
    <description>We will use DNA sequencing to define the profile of gut microbiota.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral microbiota</measure>
    <time_frame>Through study completion, an average of 4 year</time_frame>
    <description>We will use DNA sequencing to define the profile of gut microbiota.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function by Mini-mental State Examination (MMSE)</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
    <description>We will assess the cognitive function in the participants using MMSE to promote the diagnosis of AD in these participants. The sum of MMSE ranges from 0 (worse) to 30 (better).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>AD patients</arm_group_label>
    <description>Participants who are diagnosed with AD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partners of the AD patients</arm_group_label>
    <description>Partners of AD patients who live together with the AD patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly participants with normal cognition</arm_group_label>
    <description>Community dwelling elderly with normal cognition and with AD.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fecal sample collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly participants with normal congition will be collected from community. Alzheimer's&#xD;
        disease participants and their spouse will be collected from Shanghai Tenth People's&#xD;
        Hopital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60 and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with other acute gastrointestinal diseases&#xD;
&#xD;
          -  with other severe neuropsychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan Shen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuan Shen, MD, PhD</last_name>
    <phone>02166303649</phone>
    <email>kmshy@tongji.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhongyong Shi, MD</last_name>
    <phone>18701915271</phone>
    <email>szy0721@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanxia Guo, M.D.</last_name>
      <phone>021-65982875</phone>
      <email>guoyx_2000@tongji.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</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>Yuan Shen, MD, PhD</investigator_full_name>
    <investigator_title>Chief of Psychiatry Department</investigator_title>
  </responsible_party>
  <keyword>Gut Microbiota</keyword>
  <keyword>Alzheimer's Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03827733
org study id: dsyy004
nct id: NCT03827733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator will perform clinical studies to test a hypothesis that participants who
      have Alzheimer's disease will have different gut/oral microbiota profile as compared to the
      participants who do not have Alzheimer's disease. The investigators will also check the
      microbiome of their partners in this study. The investigators plan to perform the studies in
      150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai
      city. Investigators will also measure the beta-amyloid in the feces of the participants.
      Finally, the investigators will determine cognitive function in these participants.
Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant
      impact on the behavior and brain pathology consistent with Alzheimer's disease (AD)
      neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome
      and feces beta-amyloid of AD patients are different from those of the participants without AD
      and their partners. The investigators plan to recruit 150 subjects, including three groups of
      normal elders, AD patients and the partners of the AD patients. The cognitive function will
      be assessed and the feces and oral samples will be collected to determine whether there are
      differences or correlations.
observational model: Other
time perspective: Cross-Sectional
measure: Gut beta-amyloid 42
time frame: Through study completion, an average of 4 year
description: Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.
measure: Gut microbiota
time frame: Through study completion, an average of 4 year
description: We will use DNA sequencing to define the profile of gut microbiota.
measure: Oral microbiota
time frame: Through study completion, an average of 4 year
description: We will use DNA sequencing to define the profile of gut microbiota.
measure: Cognitive function by Mini-mental State Examination (MMSE)
time frame: through study completion, an average of 4 year
description: We will assess the cognitive function in the participants using MMSE to promote the diagnosis of AD in these participants. The sum of MMSE ranges from 0 (worse) to 30 (better).
arm group label: AD patients
description: Participants who are diagnosed with AD.
arm group label: Partners of the AD patients
description: Partners of AD patients who live together with the AD patients.
arm group label: Elderly participants with normal cognition
description: Community dwelling elderly with normal cognition and with AD.
Fecal sample collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yuan Shen, MD, PhD
role: Principal Investigator
affiliation: Shanghai 10th People's Hospital
last name: Yuan Shen, MD, PhD
phone: 02166303649
email: kmshy@tongji.edu.cn
last name: Zhongyong Shi, MD
phone: 18701915271
email: szy0721@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Yuan Shen, MD, PhD
investigator title: Chief of Psychiatry Department
mesh term: Alzheimer Disease
sharing ipd: Undecided