<?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>IRCT20171119037543N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-03</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Synbiotic and Antibiotic Associated Diarrhea</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effects of Synbiotic on Preventing Antibiotic Associated Diarrhea in children admitted in Imam Hosein Hospital in Isfahan City</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The type of randomization in this study is Block Randomization. In this study, Synbiotic and placebo are produced in drop forms with same shapes by pharmacology factory and get to researchers. The factory allocates an special code for each drop and researcher and patients do not have any information about the contents of drops. A table is planned and the name of patient and his/ her drop code are registered. In analyzing time, these codes and drop contents are get from factory and data are analyzed, Blinding description: In this study, researcher and patients do not have any information about contents of drops.
Drops with Synbiotics and placebo are produced by pharmacology factory in same shape and special codes are allocated for each drop. The contents of drops are get from factory in analyzing time.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Antibiotic Associated Diarrhea.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Synbiotic powder (Protexin Restore), Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by Protexin Health Care Company. Intervention 2: Control group: Placebo in powder shape, Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by faculty of Pharmacy in Isfahan University of Medical Science.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhgan Goli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 913 894 5212</telephone>
        <email>m.goli@resident.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Science, Hezar Jarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 8138</telephone>
        <email>m.goli@resident.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with 2 months to 14 years age
Children who are admitted in Imam Hosein Hospital in Isfahan City
Children who are candidate for Antibiotic therapies due to infections for equal and more than 5 days
Parent's willingness to participating in this study</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute or chronic diarrhea before starting Antibiotic
Having Antibiotic therapy during last 2 months
Having prophylactic Antibiotic treatment
Having Clostridium Difficile Associated Diarrhea during last 3 months
Having underlying gastrointestinal disease
Having central vein catheterization
Having history of using probiotics during last 7 days
Having immune deficiency
Having underlying cardiovascular disease
Having sever malnutrition or sever illness
Having long term use of medications with gastrointestinal effects</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Synbiotic powder (Protexin Restore), Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by Protexin Health Care Company</i_keyword>
      <i_keyword>Control group: Placebo in powder shape, Starting 24 hours after starting Antibiotic therapy until 7 days after finishing Antibiotic therapy, One sachet daily, produced by faculty of Pharmacy in Isfahan University of Medical Science</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of defecation. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Interview with parents.</prim_outcome>
      <prim_outcome>Stool Consistency. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Bristol Stool Scale questionnaire.</prim_outcome>
      <prim_outcome>Incidence of diarrhea. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Interview with parents.</prim_outcome>
      <prim_outcome>Diarrhea duration. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Interview with parents.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incidence of constipation. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Interview with parents.</sec_outcome>
      <sec_outcome>Presence of blood in stool. Timepoint: Every 3 days after starting Antibiotic treatment to 21 days after finishing Antibiotic treatment. Method of measurement: Interview with parents.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Science</contact_name>
        <contact_address>Imam Hosein Hospital, Imam Khomeini Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
