<?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>IRCT20161026030525N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-13</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of oral probiotic in reducing of duration of diarrhea in children with acute colitis: a double blind randomized placebo controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of oral probiotic in reducing of duration of diarrhea in children with acute colitis: a double blind randomized placebo controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to each intervention and control groups will be done using winpepi software (random block method) and using six blocks, Blinding description: Probiotic powder and placebo are similar in appearance, taste and smell. Probiotics and placebo, which are completely similar, were placed in packages in a sterile method and assigned a single code to each package. The patient and the questionnaire filler were unaware of the type of drug in the package.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Acute colitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg daily) in addition to the above treatments bulardi saccharomycesides in the form of probiotic capsules under the brand name yomogi 250. Children over 3 months receive a 250 mg capsule every 12 hours for up to 5 days (15) and in case of vomiting, the drug will be returned to the patient 15 minutes later. Intervention 2: Control group: The control group includes supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zaytoun Karmandi, Pasdaran Blvd., Tohid Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163614175</zip>
        <telephone>+98 61 3444 3051</telephone>
        <email>ahmadi-mi@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zaytoun Karmandi, Pasdaran Blvd., Tohid Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163614175</zip>
        <telephone>+98 61 3444 3051</telephone>
        <email>ahmadi-mi@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Patients 3 months to 14 years of age admitted to the hospital due to acute infectious colitis.
Patients with fever and watery stools more than 3 times a day and less than 14 days after the onset of the disease
Dysentery or the presence of more than 5 WBCs and any number of RBCs in the stool test</inclusion_criteria>
      <agemin>3 months</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Immunodeficiency
Severe abdominal distension
Severe infection or sepsis
History of gastrointestinal surgery
Use of antibiotics or probiotics in the last two weeks
Patients who have been hospitalized due to oral intolerance or lack of response to treatment The need for antibiotics other than azithromycin.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A09.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified gastroenteritis and colitis of infectious 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>Intervention group: Supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg daily) in addition to the above treatments bulardi saccharomycesides in the form of probiotic capsules under the brand name yomogi 250. Children over 3 months receive a 250 mg capsule every 12 hours for up to 5 days (15) and in case of vomiting, the drug will be returned to the patient 15 minutes later.</i_keyword>
      <i_keyword>Control group: The control group includes supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg daily)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of diarrhea. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Day.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Frequency of diarrhea. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of times of diarrhea per day.</sec_outcome>
      <sec_outcome>Duration of vomiting. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of days the patient vomits.</sec_outcome>
      <sec_outcome>Frequent vomiting. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Number of times of vomiting per day.</sec_outcome>
      <sec_outcome>Body temperature. Timepoint: Before the intervention. The first day. The third day. The fifth day. Method of measurement: Maximum temperature every 24 hours.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: End of hospitalization. Method of measurement: Number of days the patient is hospitalized.</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>Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-23</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences - School of Medicine Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
