<?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>IRCT2017041514085N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-01</date_registration>
      <primary_sponsor>Vice Chancellar of Research of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Probiotics on control of clinical features of Bronchiectasis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Probiotics on control of clinical features and exacerbation of Bronchiectasis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: After obtaining an informed consent from the subjects, they will be randomly categorized in either the control group (group A) or the placebo group (group B). In this way, the number will be assigned randomly to the patients who enter the study.This number identifies a person in one group (A is control group and B is placebo group).</study_design>
      <phase>2-3</phase>
      <hc_freetext>bronchiectasis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1(intervention group)will received routine drugs for treatment, they will treated with lactocare for 6 months. Intervention 2: Intervention group 2 (control group ) will received routine drugs for treatment and placebo during 6 months.</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>Dr Shabnam Ziapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital,  Sardar Jangal Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 133542460</telephone>
        <email>shabnam_ziapour@yahoo.com</email>
        <affiliation>Inflammatory Lung Disease Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital,  Sardar Jangal Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 3354 2460</telephone>
        <email>ali_alavi@gums.ac.ir</email>
        <affiliation>Inflammatory Lung Disease Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
More than 18 years, Not being Pregnant; &#13;
Exclusion criteria: Cardiovascular diseases; Diabetes; Use of immunosuppressive agents; Bronchiectasis due to foreign body or tumor; Disable to do spirometry</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bronchiectasis</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 1(intervention group)will received routine drugs for treatment, they will treated with lactocare for 6 months</i_keyword>
      <i_keyword>Intervention group 2 (control group ) will received routine drugs for treatment and placebo during 6 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of cough. Timepoint: The same 6 month of last year and at during of intervention. Method of measurement: by asking the person.</prim_outcome>
      <prim_outcome>Amount of sputum. Timepoint: The same 6 month of last year and before of intervention and end of sixth months. Method of measurement: by asking the person.</prim_outcome>
      <prim_outcome>Severity of dyspnea. Timepoint: The same 6 month of last year and at during of intervention. Method of measurement: by asking the person base on MRC scale.</prim_outcome>
      <prim_outcome>Results of sputum culture. Timepoint: before of intervention and end of sixth month. Method of measurement: smear and anti biogram.</prim_outcome>
      <prim_outcome>FEV1, FVC, FEV1/FVC. Timepoint: before of intervention and end of sixth month. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: before of intervention and end of sixth month. Method of measurement: weight over square of height.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need of prophylactic antibiotic for disease exacerbation. Timepoint: during of intervention. Method of measurement: by asking the person.</sec_outcome>
      <sec_outcome>Rate of hospitalizations. Timepoint: during of intervention. Method of measurement: by asking the person.</sec_outcome>
      <sec_outcome>Rate of exacerbation of disease. Timepoint: during of intervention. Method of measurement: by asking the person.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Zist Takhmir Tehran</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 Chancellar of Research of Guilan University of Medical Sciences</source_name>
      <source_name>Zist Takhmir Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-25</approval_date>
        <contact_name>Research Council of Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research of Guilan University of Medical Sciences, Gaz Avenue Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
