<?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>IRCT201205229828N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-07-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Study the effects of probiotics in the prevention of  antibiotic-associated diarrhea in children</public_title>
      <acronym></acronym>
      <scientific_title>Study the effects of probiotics in the prevention of  antibiotic-associated diarrhea in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>230</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10364</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diarrhea.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receiving Probiotic packages As a daily Prvtksyn Sasht To ten days .Probiotics contain a billion or a phrase such as Sasht 10*9 live microorganisms that are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of  probiotic ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment. Intervention 2: The control group received a placebo that are quite similar with probiotic. The control group receiving Placebo packages As a daily Prvtksyn Sasht To ten days .Placebo are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of placebo ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Partovi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>parastar st., Ahmedabad Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99199-91766</zip>
        <telephone>+98 51 1840 0001</telephone>
        <email>partovis@mums.ac.ir</email>
        <affiliation>Ghaem Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaem hospital,  parastar st., Ahmedabad Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99199-91766</zip>
        <telephone>+98 51184000019</telephone>
        <email>jafaria@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :  Children 6 months to 14 years ; Due to upper respiratory infection or ear infection ; Referred to in the first 24 hours of starting antibiotics    Exclusion criteria: Severe infection or bacterial genaralyze ;  Antibiotic treatment within 2 months before treatment ; Antibiotic prophylaxis; The use of probiotic products in recent months;Known immunodeficiency; Chronic intestinal infection; Acute and chronic diarrhea;  Use more than one type of antibiotic treatment during the period; Heart or lung disease or severe renal, Lactase deficiency is known; viral gastroenteritis (rotavirus) ;  Passing blood in the stool,Vomiting with diarrhea and severe dehydration;Incorrect or incomplete use of  antibiotics ; failure to complete treatment course</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other gastroenteritis and colitis of infectious and unspecified origin</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receiving Probiotic packages As a daily Prvtksyn Sasht To ten days .Probiotics contain a billion or a phrase such as Sasht 10*9 live microorganisms that are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of  probiotic ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment.</i_keyword>
      <i_keyword>The control group received a placebo that are quite similar with probiotic. The control group receiving Placebo packages As a daily Prvtksyn Sasht To ten days .Placebo are considered for each patient is 10 to 10 days and The code is recorded in a questionnairer.Parents are also given a questionnaire to give information about Patient,Stool consistency,Stools per day and the possible occurrence of fever,Vomiting and bloody diarrhea associated with antibiotics can reduce the risk of diarrhea,Until these issues in the event The patient should be excluded.Then at 3 and 7 days of placebo ,Presence Or telephone Information was obtained from parents and is recorded to be used in the final assessment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diarrhea. Timepoint: Over a period of more than three loose stools in 48 hours. Method of measurement: Question of the mother.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-01-01</approval_date>
        <contact_name>Mashhad University of Medical Sciences-Ghaem Hospital</contact_name>
        <contact_address>parastar st.- Ahmedabad Avenue Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
