<?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>IRCT20250824066979N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the efficacy of Vonoprazan with omeprazole in the quadruple therapy of Helicobacter pylori infection</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Vonoprazan with omeprazole in the quadruple therapy of Helicobacter pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization technique employed in this study is the block method. In this process, patients are first divided into groups of four. Next, blocks representing four different arrangements of groups A and B are defined—specifically AABB, ABAB, ABBA, BBAA, BABA, and BAAB—resulting in a total of six block types. Subsequently, Microsoft Excel is used to generate random numbers corresponding to the number of groups; the groups are then sorted based on these numbers (in ascending order) and assigned to the designated blocks. Finally, the patients previously assigned to each group are allocated to one of the intervention groups (A or B) according to the sequence established within their respective blocks.
Finally, using the numbered-envelope technique, groups A and B are assigned to either the intervention or the control group. In this way, patients are randomly distributed in equal numbers between the two study groups; Group A is designated as the intervention group, and Group B as the control group, Blinding description: In this study, a double-blind design will be used. Both the participants and the principal investigators will be completely blinded to the assignment of the study groups (study treatment or routine treatment). This will be achieved by preparing the study drug and the routine drug coded with a unique serial number, without disclosure of the drug type.

The manuscript authors will remain blinded to the identity of the groups until the completion of recruitment, database lock, and the initial analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>بیماری هلیکوباکتری پیلوری.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients presenting with symptoms of dyspepsia or epigastric pain and a positive endoscopic biopsy undergo a 14-day treatment regimen consisting of bismuth (300 mg four times daily), vonoprazan (20 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg twice daily); they are subsequently evaluated for eradication using a stool antigen test one month after the completion of treatment. Intervention 2: Control group: Patients presenting with symptoms of dyspepsia or epigastric pain and a positive endoscopic biopsy undergo a 14-day treatment regimen consisting of bismuth (300 mg four times daily), omeprazole (20 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg twice daily); they are subsequently evaluated for eradication using a stool antigen test one month after the completion of treatment.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Tavangaran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No45, 1West Kosar street, Milad town , Shahin Shahr</address>
        <city>Shahin shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8316836489</zip>
        <telephone>+98 31 4523 0036</telephone>
        <email>mahsatavangaran@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Tavangaran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No45, 1West Kosar street, Milad town , Shahin Shahr</address>
        <city>Shahin shahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8316836489</zip>
        <telephone>+98 31 4523 0036</telephone>
        <email>mahsatavangaran@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>confirmed pathology in endoscopic species or stool exam
age between 18 to 50
lack of Helicobacter pylori infection treatment  in the past 3 months
negative drug allergy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>poor compliant patients
anti-biotic therapy during the last 3 months
pregnancy or breast-feeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B96.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere</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: Patients presenting with symptoms of dyspepsia or epigastric pain and a positive endoscopic biopsy undergo a 14-day treatment regimen consisting of bismuth (300 mg four times daily), vonoprazan (20 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg twice daily); they are subsequently evaluated for eradication using a stool antigen test one month after the completion of treatment.</i_keyword>
      <i_keyword>Control group: Patients presenting with symptoms of dyspepsia or epigastric pain and a positive endoscopic biopsy undergo a 14-day treatment regimen consisting of bismuth (300 mg four times daily), omeprazole (20 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg twice daily); they are subsequently evaluated for eradication using a stool antigen test one month after the completion of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Remission. Timepoint: one month later. Method of measurement: stool exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Eradication. Timepoint: One month later. Method of measurement: stool exam.</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>IAUN</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-05</approval_date>
        <contact_name>Ethics committee of Islamic Azad University-Najaf Abad Branch</contact_name>
        <contact_address>Daneshgah Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
