<?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>IRCT20240128060832N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of moxifloxacin in Helicobacter infection</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of moxifloxacin, amoxicillin and pantoprazole regimen with clarithromycin-based four-drug regimen for eradicating Helicobacter pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>246</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People will be divided into two groups based on the first quadruple random permutation completely randomly (by a person who had no involvement in the study process). Also, matching will be done based on age and gender, Blinding description: Blinding is done in such a way that the person who performs the randomization and allocation of people to groups will not have any information about the condition of the patients. The patient and the person who examines the results will not have any information about which group the people are placed in, and the study is conducted in a double-blind manner.</study_design>
      <phase>3</phase>
      <hc_freetext>Helicobacter pylori infection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Administration of amoxicillin 1000 mg every 12 hours, moxifloxacin 400 mg every 12 hours, and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours for four weeks. Intervention 2: Control group: Administration of clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours. The watch lasts for four weeks.</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>Amir hooshang bavarsad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, Mehr East Street, Kianpars Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155635999</zip>
        <telephone>+98 61 3333 4663</telephone>
        <email>a.bavarsad@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir hooshang bavarsad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8, Mehr East Street, Kianpars Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155635999</zip>
        <telephone>+98 61 3333 4663</telephone>
        <email>a.bavarsad@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
All patients with PUD, peptic ulcer, non-ulcer dyspepsia and intestinal metaplasia (based on pathology samples) underwent endoscopic evaluation and H. pylori positive confirmation by Rapid urease test (RUT).
No previous treatment of H. pylori infection
Patient consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Taking antibiotics or non-steroidal anti-inflammatory drugs (NSAID) in the last 4 weeks
Allergy to any of the study drugs
A history of gastric surgery or the presence of a serious concurrent disease such as cancer
Pregnant or lactating women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters</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: Administration of amoxicillin 1000 mg every 12 hours, moxifloxacin 400 mg every 12 hours, and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours for four weeks.</i_keyword>
      <i_keyword>Control group: Administration of clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours. The watch lasts for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of positive or negative Helicobacter infection by fecal antigen test. Timepoint: Helicobacter test before and two weeks after treatment. Method of measurement: Helicobacter pylori fecal antigen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects. Timepoint: During treatment and two weeks after treatment. Method of measurement: Registration in the patient's self-report questionnaire.</sec_outcome>
      <sec_outcome>Acceptance of medication. Timepoint: During treatment and two weeks after treatment. Method of measurement: Registration in the patient's self-report questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-18</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Vice President of Research and Technology Development, Esfand St., Jundishapur University of Medical Sciences, Golestan Blvd., Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
