<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/NCT03273296</url>
  </required_header>
  <id_info>
    <org_study_id>1341/6.00.00/2017</org_study_id>
    <nct_id>NCT03273296</nct_id>
  </id_info>
  <brief_title>Effect of Antibiotics on Gut Microbiome and Plasma Metabolome</brief_title>
  <official_title>Effect of Antibiotics on Gut Microbiome and Plasma Metabolome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finnish Institute for Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Finnish Institute for Health and Welfare</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years it has been observed that the gut microbiome can produce metabolites into&#xD;
      systemic circulation and thus have important health effects even outside the gastrointestinal&#xD;
      system. These metabolites may play a role in the pathogenesis of common public health&#xD;
      problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass&#xD;
      spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now&#xD;
      enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort,&#xD;
      collected by the National Institute for Health and Welfare, we are currently determining the&#xD;
      gut microbiome and plasma metabolome from &gt; 7000 participants with 15 years of follow-up for&#xD;
      various health outcomes. This is one of the largest materials of its kind world-wide. The&#xD;
      design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in&#xD;
      the composition of plasma metabolome. To enable conclusions which go beyond statistical&#xD;
      associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut&#xD;
      bacteriome with a short course of antibiotics and then examine whether a change in plasma&#xD;
      metabolomics profile will follow. At the same time the trial will give important novel&#xD;
      information about the effects of commonly used antibiotics on gut bacteriome and on general&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiome</measure>
    <time_frame>Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.</time_frame>
    <description>Change in gut microbiome from baseline to repeat assessments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolome</measure>
    <time_frame>Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.</time_frame>
    <description>Change in circulating metabolome from baseline to repeat assessments.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Microbial Colonization</condition>
  <arm_group>
    <arm_group_label>Amoxicillin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Azithromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>Amoxicillin (po) 500 mg x 3 per day for 3 days.</description>
    <arm_group_label>Amoxicillin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Azithromycin (po) 500 mg x 1 on day 1, 250 mg x 1 on day 2, and 250 mg x 1 on day 3.</description>
    <arm_group_label>Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>Vancomycin (po) 125 mg x 4 per day for 3 days.</description>
    <arm_group_label>Vancomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior participation in the FINRISK 2002 survey and current residence in Helsinki&#xD;
             metropolitan area.&#xD;
&#xD;
          -  Age range 40-74 years among men and 50-74 years among women.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any antibiotic&#xD;
&#xD;
          -  A course of antibiotic during the past year&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  Any major illness (history of myocardial infarction, stroke, diabetes, liver or kidney&#xD;
             disease, cancer, psychiatric disease). Uncomplicated hypertension is allowed.&#xD;
             Likewise, statin treatment and women's hormone replacement therapy are allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Perola, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Finnish Institute for Health and Welfare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute for Health and Welfare</name>
      <address>
        <city>Helsinki</city>
        <zip>00271</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microbiota</keyword>
  <keyword>metabolize</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Vancomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03273296
org study id: 1341/6.00.00/2017
nct id: NCT03273296
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In recent years it has been observed that the gut microbiome can produce metabolites into
      systemic circulation and thus have important health effects even outside the gastrointestinal
      system. These metabolites may play a role in the pathogenesis of common public health
      problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass
      spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now
      enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort,
      collected by the National Institute for Health and Welfare, we are currently determining the
      gut microbiome and plasma metabolome from > 7000 participants with 15 years of follow-up for
      various health outcomes. This is one of the largest materials of its kind world-wide. The
      design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in
      the composition of plasma metabolome. To enable conclusions which go beyond statistical
      associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut
      bacteriome with a short course of antibiotics and then examine whether a change in plasma
      metabolomics profile will follow. At the same time the trial will give important novel
      information about the effects of commonly used antibiotics on gut bacteriome and on general
      health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Microbiome
time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
description: Change in gut microbiome from baseline to repeat assessments.
measure: Metabolome
time frame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
description: Change in circulating metabolome from baseline to repeat assessments.
arm group label: Amoxicillin
arm group type: Active Comparator
arm group label: Azithromycin
arm group type: Active Comparator
arm group label: Vancomycin
arm group type: Active Comparator
intervention type: Drug
intervention name: Amoxicillin
description: Amoxicillin (po) 500 mg x 3 per day for 3 days.
arm group label: Amoxicillin
intervention type: Drug
intervention name: Azithromycin
description: Azithromycin (po) 500 mg x 1 on day 1, 250 mg x 1 on day 2, and 250 mg x 1 on day 3.
arm group label: Azithromycin
intervention type: Drug
intervention name: Vancomycin
description: Vancomycin (po) 125 mg x 4 per day for 3 days.
arm group label: Vancomycin
criteria: 
gender: All
minimum age: 40 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markus Perola, MD, PhD
role: Principal Investigator
affiliation: Finnish Institute for Health and Welfare
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Amoxicillin
mesh term: Azithromycin
mesh term: Vancomycin
sharing ipd: Yes