<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/NCT03297242</url>
  </required_header>
  <id_info>
    <org_study_id>chbs230023</org_study_id>
    <nct_id>NCT03297242</nct_id>
  </id_info>
  <brief_title>Study the Effect of Probiotics Combined With Bismuth Quadruple Rescue Therapy on H Pylori Infective Patients</brief_title>
  <official_title>A Retrospective Study of the Efficacy of Compound Lactobacillus Acidophilus Combined With Bismuth Quadruple Rescue Therapy on Patients With H Pylori Eradication Failures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai 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>
      Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times&#xD;
      in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates&#xD;
      and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by&#xD;
      10d's bismuth, furazolidone, tetracycline contained quadruple scheme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      H pylori infection rate has been up to half of the world population. H pylori infection is&#xD;
      associated with various diseases, especially gastric cancer.&#xD;
&#xD;
      With the increasingly resistant to antibiotics,the eradication rate has decreased a lot with&#xD;
      traditional triple therapy. Exploring a valid scheem for patients who have failed multiple&#xD;
      times is important.&#xD;
&#xD;
      Probiotics can improve gastrointestinal microenvironment, then release the adverse effects&#xD;
      during the eradication process.Additionally,there is also a lot evidence that probiotics can&#xD;
      inhibit H plori，but still controversially.&#xD;
&#xD;
      There is a low resistant rate about furazolidone and tetracycline. In this study&#xD;
      investigators observe the efficacy of the therapy 2w's compound lactobacillus acidophilus&#xD;
      followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme on patients&#xD;
      who have failed more than 2 times. 4 to 6 weeks after the therapy, if Urea Breath Test (UBT)&#xD;
      is nedative which means eradicating H plori successfully.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>urea breath test</measure>
    <time_frame>4-6 weeks after the quadruple therapy</time_frame>
    <description>if urea breath test is negative,it means H pylori eradicated successfully</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>1month</time_frame>
    <description>adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        mainland in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  H pylori eradication had failed more than 2 times&#xD;
&#xD;
          -  Patients had never used furazolone and tetracycline&#xD;
&#xD;
          -  The age varied from 18 to 80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  H pylori initial eradication or had failed only 1 time&#xD;
&#xD;
          -  The age was lower than 18,or higher than 80 years old&#xD;
&#xD;
          -  Patients who had serious heart pulmonary disease ,live renal disease, or any cancers&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhao S Li, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Yi Q Du, MD</last_name>
    <phone>+86-13801993592</phone>
    <email>duyiqi@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ai R Liu, MM</last_name>
    <phone>+86-13701798230</phone>
    <email>13701798230@163.com</email>
  </overall_contact_backup>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhaoshen Li</investigator_full_name>
    <investigator_title>director of the Digestive Department</investigator_title>
  </responsible_party>
  <keyword>Helicobacter Pylori eradication</keyword>
  <!-- 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/NCT03297242
org study id: chbs230023
nct id: NCT03297242
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Retrospectivly follow-up the outpatients for H pylori eradication failures more than 2 times
      in the digestive department of Changhai hospital from 2015-2017,analyse the eradication rates
      and adverse effects of the therapy with 2w's compound lactobacillus acidophilus followed by
      10d's bismuth, furazolidone, tetracycline contained quadruple scheme.
H pylori infection rate has been up to half of the world population. H pylori infection is
      associated with various diseases, especially gastric cancer.

      With the increasingly resistant to antibiotics,the eradication rate has decreased a lot with
      traditional triple therapy. Exploring a valid scheem for patients who have failed multiple
      times is important.

      Probiotics can improve gastrointestinal microenvironment, then release the adverse effects
      during the eradication process.Additionally,there is also a lot evidence that probiotics can
      inhibit H plori，but still controversially.

      There is a low resistant rate about furazolidone and tetracycline. In this study
      investigators observe the efficacy of the therapy 2w's compound lactobacillus acidophilus
      followed by 10d's bismuth, furazolidone, tetracycline contained quadruple scheme on patients
      who have failed more than 2 times. 4 to 6 weeks after the therapy, if Urea Breath Test (UBT)
      is nedative which means eradicating H plori successfully.
observational model: Case-Only
time perspective: Retrospective
measure: urea breath test
time frame: 4-6 weeks after the quadruple therapy
description: if urea breath test is negative,it means H pylori eradicated successfully
measure: adverse effects
time frame: 1month
description: adverse effects mean the new symptoms during the treatment process,such as nausea,vomiting.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhao S Li, MD
role: Principal Investigator
last name: Yi Q Du, MD
phone: +86-13801993592
email: duyiqi@hotmail.com
last name: Ai R Liu, MM
phone: +86-13701798230
email: 13701798230@163.com
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhaoshen Li
investigator title: director of the Digestive Department