<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/NCT04415983</url>
  </required_header>
  <id_info>
    <org_study_id>helicobacter children</org_study_id>
    <nct_id>NCT04415983</nct_id>
  </id_info>
  <brief_title>Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children</brief_title>
  <official_title>Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</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>
      Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter&#xD;
      pylori in children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2030</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with cured helicobacter infection</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of patients with eradicated helicobacter infection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Nitazoxanide group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clarithromycin, Nitazoxanide and Proton pump inhibitor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clarithromycin, Metronidazole and Proton pump inhibitor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitazoxanide</intervention_name>
    <description>Nitazoxanide twice daily</description>
    <arm_group_label>Nitazoxanide group</arm_group_label>
    <other_name>nanazoxid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin</intervention_name>
    <description>Klacid twice daily</description>
    <arm_group_label>Nitazoxanide group</arm_group_label>
    <arm_group_label>Traditional group</arm_group_label>
    <other_name>Klacid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>Metronidazole twice daily</description>
    <arm_group_label>Traditional group</arm_group_label>
    <other_name>Flagyl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proton pump inhibitor</intervention_name>
    <description>Omeprazoe twice daily</description>
    <arm_group_label>Nitazoxanide group</arm_group_label>
    <arm_group_label>Traditional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Positive helicobacter infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment for H. Pylori.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rasha Gamal, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrics department - Tanta University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>sherief Abd-Elsalam, ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University Faculty of medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abeer Salamah, Lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Pediatrics department - Kafr Elsheikh University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>dina shawky, lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Pediatrics department - Tanta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherief Abd-Elsalam, Ass. Prof.</last_name>
      <phone>00201009221243</phone>
      <email>sheriefabdelsalam@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Nitazoxanide</mesh_term>
    <mesh_term>Proton Pump Inhibitors</mesh_term>
  </intervention_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/NCT04415983
org study id: helicobacter children
nct id: NCT04415983
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children
Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter
      pylori in children
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of patients with cured helicobacter infection
time frame: 6 months
description: Total number of patients with eradicated helicobacter infection
arm group label: Nitazoxanide group
arm group type: Experimental
description: Clarithromycin, Nitazoxanide and Proton pump inhibitor
arm group label: Traditional group
arm group type: Active Comparator
description: Clarithromycin, Metronidazole and Proton pump inhibitor
intervention type: Drug
intervention name: Nitazoxanide
description: Nitazoxanide twice daily
arm group label: Nitazoxanide group
other name: nanazoxid
intervention type: Drug
intervention name: Clarithromycin
description: Klacid twice daily
arm group label: Nitazoxanide group
arm group label: Traditional group
other name: Klacid
intervention type: Drug
intervention name: Metronidazole
description: Metronidazole twice daily
arm group label: Traditional group
other name: Flagyl
intervention type: Drug
intervention name: Proton pump inhibitor
description: Omeprazoe twice daily
arm group label: Nitazoxanide group
arm group label: Traditional group
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Rasha Gamal, Ass. Prof.
role: Principal Investigator
affiliation: Pediatrics department - Tanta University
last name: sherief Abd-Elsalam, ass. Prof.
role: Principal Investigator
affiliation: Tanta University Faculty of medicine
last name: Abeer Salamah, Lecturer
role: Study Director
affiliation: Pediatrics department - Kafr Elsheikh University
last name: dina shawky, lecturer
role: Study Director
affiliation: Pediatrics department - Tanta University
last name: Sherief Abd-Elsalam, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Nitazoxanide
mesh term: Proton Pump Inhibitors
sharing ipd: No