<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/NCT03756623</url>
  </required_header>
  <id_info>
    <org_study_id>microbiome2018</org_study_id>
    <nct_id>NCT03756623</nct_id>
  </id_info>
  <brief_title>Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects</brief_title>
  <official_title>Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects: a Randomized, Double-blind Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
      This clinical trial is designed to evaluate the alteration of gut microbiome in healthy&#xD;
      subjects after a 12-week metformin and/or probiotics administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gut microbiome dysbiosis have been linked with the onset and progression of several diseases.&#xD;
      Metformin and probiotics have been confirmed to function partly by regulating the gut&#xD;
      microbiome. The investigators are now wondering if metformin/probiotics treatment will change&#xD;
      the gut microbiota in healthy subjects and show some benefits.&#xD;
&#xD;
      In this study, about 60 healthy subjects will be enrolled. Participants will be randomly&#xD;
      assigned into one of the following three groups: Metformin powder (0.5g tid po), Probiotics&#xD;
      powder (0.5g tid po), Placebo powder (0.5g tid po), for 12 weeks.&#xD;
&#xD;
      Blood and stool samples will be collected before and after treatment. Fasting glucose levels,&#xD;
      fasting insulin levels, serum lipid profiles, inflammation markers and alteration of gut&#xD;
      microbiota will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gut microbiota alterations</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gut microbiota composition and function will be assessed before and after study.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Drug: Metformin powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5g of Metformin powder administered three times a day orally before meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Probiotics powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5g of Probiotics powder administered three times a day orally before meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Placebo powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.5g of Placebo powder administered three times a day orally before meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin powder</intervention_name>
    <description>0.5g of Metformin powder administered three times a day orally before meal</description>
    <arm_group_label>Drug: Metformin powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotics powder</intervention_name>
    <description>0.5g of Probiotics powder administered three times a day orally before meal</description>
    <arm_group_label>Drug: Probiotics powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo powder</intervention_name>
    <description>0.5g of Placebo powder administered three times a day orally before meal</description>
    <arm_group_label>Drug: Placebo powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 20-60 years of age.&#xD;
&#xD;
          2. Healthy subjects without known diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. During pregnancy and lactation period.&#xD;
&#xD;
          2. Impaired liver function, impaired renal function, mental disease, severe infection,&#xD;
             severe anemia, severe heart disease and neutropenia disease.&#xD;
&#xD;
          3. Use of metformin/antibiotics within 3 months.&#xD;
&#xD;
          4. Immunodeficient or use of immunosuppressive drugs.&#xD;
&#xD;
          5. Previous history of gastrointestinal surgery or diseases (such as peptic ulcer,&#xD;
             irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal&#xD;
             disorder).&#xD;
&#xD;
          6. Medical conditions or diseases that may affect subject safety or confound study&#xD;
             results in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mingming Zhang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drum Tower hospital affiliated to Nanjing University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Mingming Zhang</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_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/NCT03756623
org study id: microbiome2018
nct id: NCT03756623
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial is designed to evaluate the alteration of gut microbiome in healthy
      subjects after a 12-week metformin and/or probiotics administration.
Gut microbiome dysbiosis have been linked with the onset and progression of several diseases.
      Metformin and probiotics have been confirmed to function partly by regulating the gut
      microbiome. The investigators are now wondering if metformin/probiotics treatment will change
      the gut microbiota in healthy subjects and show some benefits.

      In this study, about 60 healthy subjects will be enrolled. Participants will be randomly
      assigned into one of the following three groups: Metformin powder (0.5g tid po), Probiotics
      powder (0.5g tid po), Placebo powder (0.5g tid po), for 12 weeks.

      Blood and stool samples will be collected before and after treatment. Fasting glucose levels,
      fasting insulin levels, serum lipid profiles, inflammation markers and alteration of gut
      microbiota will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gut microbiota alterations
time frame: 12 weeks
description: Gut microbiota composition and function will be assessed before and after study.
arm group label: Drug: Metformin powder
arm group type: Experimental
description: 0.5g of Metformin powder administered three times a day orally before meal
arm group label: Drug: Probiotics powder
arm group type: Experimental
description: 0.5g of Probiotics powder administered three times a day orally before meal
arm group label: Drug: Placebo powder
arm group type: Placebo Comparator
description: 0.5g of Placebo powder administered three times a day orally before meal
intervention type: Drug
intervention name: Metformin powder
description: 0.5g of Metformin powder administered three times a day orally before meal
arm group label: Drug: Metformin powder
intervention type: Drug
intervention name: Probiotics powder
description: 0.5g of Probiotics powder administered three times a day orally before meal
arm group label: Drug: Probiotics powder
intervention type: Other
intervention name: Placebo powder
description: 0.5g of Placebo powder administered three times a day orally before meal
arm group label: Drug: Placebo powder
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mingming Zhang, MD,PhD
role: Principal Investigator
affiliation: Drum Tower hospital affiliated to Nanjing University Medical School
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Mingming Zhang
investigator title: Physician
mesh term: Metformin
sharing ipd: Undecided