<?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>IRCT20210719051943N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-06</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Eradicate Helicobacter pylori infection</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effectiveness of Treatment by piloshot Probiotic and Standard Quadruple Regimen in Patients with Helicobacter Pylori</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method  will be used and the block size is 4.
Considering our sample size equal 200, we used 50 blocks.
The selection among 6 possible blocks will be conducted based on simple random sampling.
6 possible blocks are including AABB, ABAB, BBAA,  BABA, ABBA, BAAB, Blinding description: After completing the entry criteria and obtaining informed consent, patients are referred to a caregiver to receive medication.At this stage, the caregiver accidentally gives the patient drug packages that include groups A and B.The patient, the researcher, and the caregiver have no say in the selection.After completing the treatment process by patients and follow-up to eradicate, the examination begins as to which patient has taken which drug.Thus, none of the groups of researchers, participants and caregivers are involved in the choice of treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Helicobacter Pylori.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients in the control group will be treated with the four-drug regimen of two capsules of amoxicillin 500 every 12 hours,one clarithromycin 500 capsules every 12 hours,one pantoprazole 40 every 12 hours,two bismuth tablets every 12 hours with 2 placebo of piloshot daily(contains lactose mesh 200,ac-di-sol,talc,colloidal silicon dioxide and magnesium stearate). Intervention 2: Intervention group: :Patients in the intervention group under the helicobacter pylori eradication will be treated with four-drug regimen, including two capsules of amoxicillin 500 every 12 hours plus one clarithromycin 500 capsules every 12 hours and two bismuth tablets every 12 hours plus one pantoprazole 40 every 12 hours will be accompanied by 2 capsules of Pilochet (containing Lactobacillus ruteri, casei ,Acidophilus and Bifidobacterium) daily.</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 The results of the study should be reviewed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Pezeshki Modares</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Blvd. Shahid Beheshti Hospital</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719964797</zip>
        <telephone>+98 25 3612 2526</telephone>
        <email>mpezeshkim@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Pezeshki Modares</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Blvd. Shahid Beheshti Hospital</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3719964797</zip>
        <telephone>+98 25 3612 2000</telephone>
        <email>mpezeshkim@muq.ac.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infection with Helicobacter pylori  based on urease test results on endoscopic tissue samples
Age over 18 years
Indications for Helicobacter pylori eradication treatment
Satisfaction to enter the project and perform endoscopy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with participating in the project
Dissatisfaction or possibility of endoscopy
No endoscopic indication
History of treatment failure
History of drug allergy or contraindication to amoxicillin, clarithromycin and bismuth
Take another herbal medicine or probiotic at the same time</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>Control group: Patients in the control group will be treated with the four-drug regimen of two capsules of amoxicillin 500 every 12 hours,one clarithromycin 500 capsules every 12 hours,one pantoprazole 40 every 12 hours,two bismuth tablets every 12 hours with 2 placebo of piloshot daily(contains lactose mesh 200,ac-di-sol,talc,colloidal silicon dioxide and magnesium stearate)</i_keyword>
      <i_keyword>Intervention group: :Patients in the intervention group under the helicobacter pylori eradication will be treated with four-drug regimen, including two capsules of amoxicillin 500 every 12 hours plus one clarithromycin 500 capsules every 12 hours and two bismuth tablets every 12 hours plus one pantoprazole 40 every 12 hours will be accompanied by 2 capsules of Pilochet (containing Lactobacillus ruteri, casei ,Acidophilus and Bifidobacterium) daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eradicate Helicobacter pylori infection. Timepoint: Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules  piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment. Method of measurement: Bacterial fecal antigen test.</prim_outcome>
      <prim_outcome>Drug side effects. Timepoint: Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules  piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Clinical symptoms after treatment. Timepoint: Patients in the intervention group underwent a four-drug regimen for Helicobacter pylori eradication, including amoxicillin capsules plus clarithromycin capsules and bismuth tablets plus pantoprazole, plus 2 capsules  piloshot daily,and patients in the control group will be treated with the above four-drug regimen along with 2 placebo tablets of Pilochat drug daily. The duration of the treatment period will be 14 days. Helicobacter pylori will be followed up after treatment. Method of measurement: questionnaire.</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-02</approval_date>
        <contact_name>Research Ethics Committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Beheshti Blvd. Shahid Beheshti Hospital Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
