<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/NCT03794401</url>
  </required_header>
  <id_info>
    <org_study_id>07-XD-074</org_study_id>
    <nct_id>NCT03794401</nct_id>
  </id_info>
  <brief_title>Alternations of Intestinal Microbiota and Health Impact in CKD</brief_title>
  <official_title>Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</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>
      This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their&#xD;
      interactions on clinical outcomes among patient with CKD stage 3-5.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>renal outcome</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiovascular outcome</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>all-cause mortality</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>CV death or non-CV death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurological outcome</measure>
    <time_frame>3-year follow-up</time_frame>
    <description>the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years</measure>
    <time_frame>2-year</time_frame>
    <description>the change of lean body mass</description>
  </other_outcome>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum, white cells, urine, feces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Regional Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with CKD stage 3-5 defined as eGFR &lt;60 ml/min/1.73 m2 calculated with the use&#xD;
             of the four-variable Modification of Diet in Renal Disease formula who have not yet on&#xD;
             dialysis therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active cancer&#xD;
&#xD;
          -  Patients with liver cirrhosis&#xD;
&#xD;
          -  Patients have taken antibiotics within three months before screening for inclusion.&#xD;
&#xD;
          -  Patients with a cardiac pacemaker or metallic implants,&#xD;
&#xD;
          -  Patients are amputees&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with inherited renal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>SZU-CHUNG HUNG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>TING-YUN LIN</last_name>
    <phone>+886-2-66289779</phone>
    <phone_ext>2350</phone_ext>
    <email>water_h2o_6@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Tzu Chi Hospital</name>
      <address>
        <city>New Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Szu-Chun Hung, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</investigator_affiliation>
    <investigator_full_name>Szu-Chun Hung</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>body composition</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>dietary pattern</keyword>
  <keyword>gut microbiot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03794401
org study id: 07-XD-074
nct id: NCT03794401
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their
      interactions on clinical outcomes among patient with CKD stage 3-5.
observational model: Cohort
time perspective: Prospective
measure: renal outcome
time frame: 3-year follow-up
description: a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
measure: cardiovascular outcome
time frame: 3-year follow-up
description: a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
measure: all-cause mortality
time frame: 3-year follow-up
description: CV death or non-CV death
measure: neurological outcome
time frame: 3-year follow-up
description: the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years
measure: change of lean body mass, measured by bioimpedance spectroscopy every 3 months for 2 years
time frame: 2-year
description: the change of lean body mass
whole blood, serum, white cells, urine, feces
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: SZU-CHUNG HUNG
role: Principal Investigator
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
last name: TING-YUN LIN
phone: +886-2-66289779
phone ext: 2350
email: water_h2o_6@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
investigator full name: Szu-Chun Hung
investigator title: Attending physician
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic