<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/NCT04449185</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0621</org_study_id>
    <nct_id>NCT04449185</nct_id>
  </id_info>
  <brief_title>Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia</brief_title>
  <official_title>Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 aims of the investigators' study are to investigate the effect of H.pylori eradication on&#xD;
      the human gut microbiome and symptoms of functional dyspepsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accumulating evidence shows that Helicobacter pylori protects against some metabolic and&#xD;
      immunological diseases in which the development of these diseases coincide with temporal or&#xD;
      permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve&#xD;
      symptoms of functional dyspepsia. The aims of our study are to investigate the effect of&#xD;
      H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of gut microbiome</measure>
    <time_frame>at 3 months, and 6 months</time_frame>
    <description>Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom of dyspepsia</measure>
    <time_frame>at 3 months, and 6 months</time_frame>
    <description>Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eradication of helicobacter pylori</measure>
    <time_frame>at 3 months</time_frame>
    <description>Eradication rate of helicobacter pylori at 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histologic finding of UGI tract</measure>
    <time_frame>at initial and 3 months</time_frame>
    <description>Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dyspepsia</condition>
  <arm_group>
    <arm_group_label>HP eradication group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HP eradication group&#xD;
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days</intervention_name>
    <description>Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days</description>
    <arm_group_label>HP eradication group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who has diagnosed with functional dyspesia by Rome IV criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known GI malignancy&#xD;
&#xD;
          -  Previous Helicobater pylori eradication history&#xD;
&#xD;
          -  Severe systemic disease&#xD;
&#xD;
          -  Previous GI surgery&#xD;
&#xD;
          -  Uncorrectable coagulopathy: INR &gt; 1.5 or platelet &lt; 50,000/ml&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Atrophic gastritis, open type&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kee Wook Jung, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kee Wook Jung, MD, PhD</last_name>
    <phone>821026778856</phone>
    <email>jung.keewook30@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ga Hee Kim, MD, PhD</last_name>
    <phone>821028732884</phone>
    <email>smallgh@hanmail.net</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Kee Wook Jung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dyspepsia</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Eradication therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
  </intervention_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/NCT04449185
org study id: 2020-0621
nct id: NCT04449185
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aims of the investigators' study are to investigate the effect of H.pylori eradication on
      the human gut microbiome and symptoms of functional dyspepsia.
Accumulating evidence shows that Helicobacter pylori protects against some metabolic and
      immunological diseases in which the development of these diseases coincide with temporal or
      permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve
      symptoms of functional dyspepsia. The aims of our study are to investigate the effect of
      H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of gut microbiome
time frame: at 3 months, and 6 months
description: Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
measure: Symptom of dyspepsia
time frame: at 3 months, and 6 months
description: Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
measure: Eradication of helicobacter pylori
time frame: at 3 months
description: Eradication rate of helicobacter pylori at 3 months
measure: Histologic finding of UGI tract
time frame: at initial and 3 months
description: Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
arm group label: HP eradication group
arm group type: Experimental
description: HP eradication group
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
intervention type: Drug
intervention name: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
description: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
arm group label: HP eradication group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kee Wook Jung, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
last name: Kee Wook Jung, MD, PhD
phone: 821026778856
email: jung.keewook30@gmail.com
last name: Ga Hee Kim, MD, PhD
phone: 821028732884
email: smallgh@hanmail.net
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Kee Wook Jung
investigator title: Professor
mesh term: Dyspepsia
mesh term: Amoxicillin
mesh term: Clarithromycin