<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230612058464N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-24</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Helicobacter pylori eradication treatment in children with chronic gastritis with non-eradication treatment of Helicobacter pylori in patients with chronic gastritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Helicobacter pylori eradication treatment in children with chronic gastritis with non-eradication treatment of Helicobacter pylori in patients with chronic gastritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70643</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization will be a simple randomization, so that 2 cards with the letters A and B are placed in front of the patient's parents and they choose one. Each letter belongs to one of 2 groups, Blinding description: According to the Helicobacter pylori treatment guidelines, both treatments are approved, and at the beginning of the study, the method of treatment will be explained to the parents of the participants, and only the parents will know about the type of treatment and the child will not know about the type of treatment, so the study is a single-blind study.</study_design>
      <phase>3</phase>
      <hc_freetext>Helicobacter positive chronic gastritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A group of 20 children in such a way that the first 10 days of sequential therapy with S-Omeprazole 2 mg/kg/day in two divided doses and simultaneous Helicobacter pylori antibiotic treatment, first a 5-day course of amoxicillin 50 mg/kg/day in two divided doses And then on the second 5 days, they will receive clarithromycin 15 mg/kg/day in two divided doses and metronidazole 20 mg/kg/day in two divided doses, and then they will receive omeprazole 1 mg/kg/day in a single daily dose for 50 days. Helicobacter pylori antigen in stool is checked 4-8 weeks after the eradication treatment to ensure the treatment. Intervention 2: Intervention group: Group B, 20 children only proton pump inhibitor.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hassan Talakesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord - Parastar St. - Hajar Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>talakesh.h@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Talakesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord - Parastar St. - Hajar Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۵۷۱۳۴۷۱</zip>
        <telephone>+98 38 3222 0016</telephone>
        <email>talakesh.h@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parental consent to participate in the study
Patients with no history of stomach cancer in children with Helicobacter pylori positive chronic gastritis, which is positive at the same time as the patient's RUT test, and the patient's history and clinical examination with the patient's endoscopic view and pathology report according to first degree relatives</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of parental consent to participate in the study
Evidence of ulcers or any other pathology other than chronic gastritis in the stomach, esophagus and duodenum.
Functional abdominal pain.
Mallet's lymphoma.
Hemi-sideroplastic anemia
ITP
Hiatal hernia
Patients with history of stomach cancer in first-degree relatives</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized abdominal pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A group of 20 children in such a way that the first 10 days of sequential therapy with S-Omeprazole 2 mg/kg/day in two divided doses and simultaneous Helicobacter pylori antibiotic treatment, first a 5-day course of amoxicillin 50 mg/kg/day in two divided doses And then on the second 5 days, they will receive clarithromycin 15 mg/kg/day in two divided doses and metronidazole 20 mg/kg/day in two divided doses, and then they will receive omeprazole 1 mg/kg/day in a single daily dose for 50 days. Helicobacter pylori antigen in stool is checked 4-8 weeks after the eradication treatment to ensure the treatment.</i_keyword>
      <i_keyword>Intervention group: Group B, 20 children only proton pump inhibitor</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Regurgitation frequency. Timepoint: before the study and after 2 months and after 4 months of treatment. Method of measurement: number.</prim_outcome>
      <prim_outcome>Frequent heartburn. Timepoint: before the study and after 2 months and after 4 months of treatment. Method of measurement: number.</prim_outcome>
      <prim_outcome>Vomiting frequency. Timepoint: before the study and after 2 months and after 4 months of treatment. Method of measurement: number.</prim_outcome>
      <prim_outcome>Abdominal pain frequency localized poorly. Timepoint: before the study and after 2 months and after 4 months of treatment. Method of measurement: number.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-12</approval_date>
        <contact_name>Ethics committee of Shahre-kord University of Medical Sciences</contact_name>
        <contact_address>8, Fourth Ave., Shariati Blvd. Shahrekord city Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
