<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/NCT03837990</url>
  </required_header>
  <id_info>
    <org_study_id>20181011/20-2018-80/112</org_study_id>
    <nct_id>NCT03837990</nct_id>
  </id_info>
  <brief_title>One Sequencing Find All for Helicobacter Pylori Infection</brief_title>
  <official_title>Development of Prediction Model of Treatment Outcome of Helicobacter Pylori Eradication Through &quot;One Sequencing Find All&quot; Approach: With Whole Exome Sequencing for Host and Target Sequencing for Bacteria at Once</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The aim of this study is to Identify antibiotic resistance gene mutations in Helicobacter&#xD;
      pylori (HP) and genetic diversity of drug metabolism for antibiotics and proton pump&#xD;
      inhibitors (PPIs) in patients with HP infection using next-generation sequencing (NGS). The&#xD;
      mutation of host/HP strain will be investigated by single NGS, and the eradication results&#xD;
      according to genetic polymorphism of host/HP strain will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational study for the Helicobacter pylori (HP) infected&#xD;
      patients on typical gastroduodenoscopy (EGD) at Boramae Hospital, Seoul, Korea.&#xD;
&#xD;
      The presence of antibiotic resistance genes of HP and the diversity of the pharmacokinetic&#xD;
      genotypes of the subjects will be investigated by performing single next-generation&#xD;
      sequencing (NGS) analysis using gastric mucosal tissue samples of the HP infected subjects.&#xD;
&#xD;
      The purpose of this study is to collect data on the antimicrobial resistance mutation of HP&#xD;
      (23S rRNA gene, pbp1 gene, rdxA, frxA, frxB gene, 16S rRNA, gyrA, gyrB gene, and Cag A gene)&#xD;
      and to investigate the genetic diversity on the metabolism of antibiotics and proton pump&#xD;
      inhibitors (CYP enzyme) in a Korean population.&#xD;
&#xD;
      The investigators are going to compare the results of standard eradication therapy according&#xD;
      to the resistance mutation of HP and drug genetic diversity of subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication rate of HP infection</measure>
    <time_frame>12 months</time_frame>
    <description>intent to treat and per protocol analysis</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Resistant Infection</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Helicobacter Pylori eradication therapy</intervention_name>
    <description>Eradication therapy includes the administration of a proton pump inhibitor (PPI) and antibiotics. Triple therapy with a PPI (lansoprazole or esomeprazole), clarithromycin, and amoxicillin is the first-line regimen. Quadruple therapy with a PPI, bismuth, metronidazole, and tetracyclin is the second-line therapy.</description>
    <other_name>next-generation sequencing of HP strain and host</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gastric mucosal tissue sample will be used by remnant tissue of CLO test during&#xD;
      gastroduodenoscopy. To protect information of participants, we plan to encrypt/anonymize all&#xD;
      identifiers of the subjects and store them in a separate database. Whole genome data will be&#xD;
      stored in the database of the laboratory of Seoul National University Hospital, and the&#xD;
      patient's medical record information (EMR data) will be stored separately.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        H. pylori-positive healthy patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years old&#xD;
&#xD;
          -  CLO test positive&#xD;
&#xD;
          -  Findings of gastric ulcer, atrophic gastritis on gastroduodenoscopy&#xD;
&#xD;
          -  Agreed to HP eradication therapy and accept to follow-up&#xD;
&#xD;
          -  Agreed to participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous HP eradication treatment&#xD;
&#xD;
          -  History of partial gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ju Han Kim, MD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Biomedical Informatics,Seoul National University College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jung Ho Bae, MD</last_name>
    <phone>82-10-35827713</phone>
    <phone_ext>2112-5570</phone_ext>
    <email>newsanapd@naver.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ji Won Kim, MD</last_name>
    <phone>82-10-4279-7028</phone>
    <email>kjwjor@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>서울특별시</state>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jungho bae, MD</last_name>
      <phone>1035827713</phone>
      <email>newsanapd@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.</citation>
    <PMID>20525969</PMID>
  </reference>
  <reference>
    <citation>Sugimoto M, Furuta T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400.</citation>
    <PMID>24914361</PMID>
  </reference>
  <reference>
    <citation>Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.</citation>
    <PMID>27707777</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>May 12, 2019</last_update_submitted>
  <last_update_submitted_qc>May 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Whole genome sequencing</keyword>
  <keyword>Polymorphism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Helicobacter Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03837990
org study id: 20181011/20-2018-80/112
nct id: NCT03837990
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to Identify antibiotic resistance gene mutations in Helicobacter
      pylori (HP) and genetic diversity of drug metabolism for antibiotics and proton pump
      inhibitors (PPIs) in patients with HP infection using next-generation sequencing (NGS). The
      mutation of host/HP strain will be investigated by single NGS, and the eradication results
      according to genetic polymorphism of host/HP strain will be analyzed.
This study is a prospective observational study for the Helicobacter pylori (HP) infected
      patients on typical gastroduodenoscopy (EGD) at Boramae Hospital, Seoul, Korea.

      The presence of antibiotic resistance genes of HP and the diversity of the pharmacokinetic
      genotypes of the subjects will be investigated by performing single next-generation
      sequencing (NGS) analysis using gastric mucosal tissue samples of the HP infected subjects.

      The purpose of this study is to collect data on the antimicrobial resistance mutation of HP
      (23S rRNA gene, pbp1 gene, rdxA, frxA, frxB gene, 16S rRNA, gyrA, gyrB gene, and Cag A gene)
      and to investigate the genetic diversity on the metabolism of antibiotics and proton pump
      inhibitors (CYP enzyme) in a Korean population.

      The investigators are going to compare the results of standard eradication therapy according
      to the resistance mutation of HP and drug genetic diversity of subjects.
observational model: Case-Only
time perspective: Prospective
measure: Eradication rate of HP infection
time frame: 12 months
description: intent to treat and per protocol analysis
intervention type: Drug
intervention name: Helicobacter Pylori eradication therapy
description: Eradication therapy includes the administration of a proton pump inhibitor (PPI) and antibiotics. Triple therapy with a PPI (lansoprazole or esomeprazole), clarithromycin, and amoxicillin is the first-line regimen. Quadruple therapy with a PPI, bismuth, metronidazole, and tetracyclin is the second-line therapy.
other name: next-generation sequencing of HP strain and host
Gastric mucosal tissue sample will be used by remnant tissue of CLO test during
      gastroduodenoscopy. To protect information of participants, we plan to encrypt/anonymize all
      identifiers of the subjects and store them in a separate database. Whole genome data will be
      stored in the database of the laboratory of Seoul National University Hospital, and the
      patient's medical record information (EMR data) will be stored separately.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Ju Han Kim, MD
role: Study Director
affiliation: Division of Biomedical Informatics,Seoul National University College of Medicine
last name: Jung Ho Bae, MD
phone: 82-10-35827713
phone ext: 2112-5570
email: newsanapd@naver.com
last name: Ji Won Kim, MD
phone: 82-10-4279-7028
email: kjwjor@snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
PMID: 20525969
citation: Sugimoto M, Furuta T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400.
PMID: 24914361
citation: Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
PMID: 27707777
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Helicobacter Infections
sharing ipd: No