<?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>IRCT20150622022869N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-11</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of OABM WITH  OABF regimens in In the treatment of Helicobacter pylori patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of OABM WITH  OABF regimens in In the treatment of Helicobacter pylori patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table method is used for randomization in this study. In this method, random table is used for randomization and patients are assigned random numbers from the table. Patients in each of the two study groups will be assigned to one of the two groups based on random numbers, Blinding description: The present study will be single blind, in which the researchers of this study will be blinded to the type of intervention assigned to the patients.</study_design>
      <phase>3</phase>
      <hc_freetext>helicobacter pylori (h. pylori) infection.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: omeprazole 20 mg twice a day (Bid) is continued for two weeks with antibiotics and then for 6 weeks without antibiotics, and after 4 weeks of this treatment period, the patient gives a stool antigen test to check the eradication of Helicobacter pylori. Amoxicillin 1 gram twice a day, bismuth citrate tablets twice a day and furazolidone 200 mg twice a day (Bid). Intervention 2: Second intervention group: omeprazole 20 mg twice a day along with antibiotics for 2 weeks and then for 6 weeks without antibiotics and alone and after this 6-week period, the patient will refer to stool antigen test method 4 weeks later without taking drugs and antibiotics for eradication test. In this group, amoxicillin one gram twice in day and two tablets of bismuth citrate twice a day (4 tablets a day) and metronidazole 500 mg twice a day.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data of this study can be shared without mentioning individuals and in aggregate form after the publication of the article through administrative correspondence.

When:
After printing the article

To whom:
this is available for people working in academic institutions or people working in businesses can also apply to receive it.

Conditions:
Any analysis on the data will be allowed

Where to obtain:
m.sedaghattalab@yuma.ac.com

How to obtain:
After sending the email, the required data will be available for up to 1 month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moslem Sedaghttalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3334 5876</telephone>
        <email>m.sedaghattalab@yuma.ac.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moslem Sedaghttalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Jalil St., campus of Yasouj University of Medical Sciences,. Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3334 5876</telephone>
        <email>m.sedaghattalab@yuma.ac.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A patient who underwent endoscopy and has peptic ulcer disease (PUD).
Patients with dyspepsia without endoscopic indication have a positive Helicobacter diagnostic test, including Helicobacter stool antigen test and....
Patients with maltoma
Endoscopy patients with nud (non-ulcer dyspepsia) and patients with a history of cancer in their first degree relatives will be included in the study.
Patients who have a history of pud and are Helicobacter positive and are taking NSAID
Treatment-resistant dyspepsia
Patient satisfaction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous history of H pylori treatment
Allergy to antibiotics
Allergy to PPI
History of gastrectomy
Having gastric cancer
pregnant women
Taking antibiotics in the last month
Taking PPI or h2blocker in the last two weeks
Chronic liver, kidney or lung disease
History of Fauvism</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>First intervention group: omeprazole 20 mg twice a day (Bid) is continued for two weeks with antibiotics and then for 6 weeks without antibiotics, and after 4 weeks of this treatment period, the patient gives a stool antigen test to check the eradication of Helicobacter pylori. Amoxicillin 1 gram twice a day, bismuth citrate tablets twice a day and furazolidone 200 mg twice a day (Bid)</i_keyword>
      <i_keyword>Second intervention group: omeprazole 20 mg twice a day along with antibiotics for 2 weeks and then for 6 weeks without antibiotics and alone and after this 6-week period, the patient will refer to stool antigen test method 4 weeks later without taking drugs and antibiotics for eradication test. In this group, amoxicillin one gram twice in day and two tablets of bismuth citrate twice a day (4 tablets a day) and metronidazole 500 mg twice a day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency distribution of Helicobacter pylori antigen negativity. Timepoint: 12weeks after the start of the study. Method of measurement: Stool antigen test.</prim_outcome>
      <prim_outcome>Drug side effects. Timepoint: 12 weeks. Method of measurement: Clinical examination and patient presentation.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-03</approval_date>
        <contact_name>Ethics committee ofYasuj University of Medical Sciences</contact_name>
        <contact_address>Dr. Jalil St., campus of Yasouj University of Medical Sciences., Yasuj., Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
