<?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>IRCT2012122311849N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-19</date_registration>
      <primary_sponsor>self financial</primary_sponsor>
      <public_title>Probiotic yogurt effects on health status and performance of endurance adolescent female swimmer</public_title>
      <acronym></acronym>
      <scientific_title>Probiotic yogurt effects on performance, respiratory and digestive system of endurance adolescent female swimmers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12032</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Performance and respiratory and digestive disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : Receiving 400 ml yogurt Probiotic containing 4 × 1010 cfu/ml (Colony forming unit per millimeter) comprising of Lactobacillus Acidophilus SPP, Lactobacillus Delbrueckii Bulgaricus, Bifidobacterium Bifidum, and Streptococcus Salivarus Thermnophilus, (n=23) and group. Intervention 2: Control group: Receiving similar dose of ordinary yogurt.</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>Leili Ghadamli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7484</telephone>
        <email>leylee61@yahoo.com</email>
        <affiliation>, International Branch, Shahid Beheshti University of Medical Sciences, Tehran, Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Salarkia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2235 7484</telephone>
        <email>n_salarkia@hotmail.com,  nahidsalarkia@yahoo.com</email>
        <affiliation>National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Te</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :being healthy; having the 400 meter crawl swimming time less than 6 min. 20 Sec . Exclusion criteria: acute gastrointestinal symptoms ; intake antibiotics for two months before the study.</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>17 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J00,J02,J0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>common cold, Sore throat, Influenza, Gastro-oesophageal reflux disease</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 : Receiving 400 ml yogurt Probiotic containing 4 × 1010 cfu/ml (Colony forming unit per millimeter) comprising of Lactobacillus Acidophilus SPP, Lactobacillus Delbrueckii Bulgaricus, Bifidobacterium Bifidum, and Streptococcus Salivarus Thermnophilus, (n=23) and group</i_keyword>
      <i_keyword>Control group: Receiving similar dose of ordinary yogurt</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>VO2max. Timepoint: Harvard Step test will be employed to measure VO2max will be performed at the beginning and end of week eight. Method of measurement: Harvard Step test will be employed to measure VO2max. The athlete step up and down off a 41cm high bench for 3 minutes at a rate 22 steps/minute. On finishing the test the number of heart beats will be counted for 15 seconds. The number of beats will be multiplied in 15 seconds by 4 to give the "step test pulse rate". This final value will be used to assess the athlete's VO2max in ml/kg/min.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stomachache, vomiting and diarrhea; respiratory infections such as: rhinitis, fever, sore throat, cough, chest ailing breath by sound, ear pain. Timepoint: at the beginning and end of week eight. Method of measurement: All subjects will be asked to record the digestive symptoms such as:  stomachache, vomiting and diarrhea; respiratory infections such as: rhinitis, fever, sore throat, cough, chest ailing breath by sound, ear pain; the extent of exercise per meter; the intake of medicine and quantity of the consumed foodstuff  product which had been recommended, on the provided questionnaires, daily. The subjects will be advised to refrain from other probiotic products which were outside the project plan.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>self financial</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>self financial</source_name>
      <source_name>self financial</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>National Nutrition and Food Technology Research Institute</contact_name>
        <contact_address>46, West Arghavan St., Farahzadi Blv. Shahrak-E-Qods. Tehran, POBOX 19395-4741, IRAN, Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
