<?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>IRCT20161215031429N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of probiotics on allergic rhinitis and asthma</public_title>
      <acronym></acronym>
      <scientific_title>The effects of probiotic on clinical findings in patients with allergic rhinitis and asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24724</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the primary visit, the participants who meet the inclusion criteria will be allocated by randomization software into two groups. The random allocation will be done through blocks of size 8 in order to make balance in number between male and female, Blinding description: After signing informed consent by all participants, the participants will be numbered by a tertiary investigator and the numbers will be entered to the randomization software. After allocating the participants to the two groups by randomization software, the case and control groups will be determined. Then the supplements and placebo will be given to the secondary investigator, who is blind to the sequence of entering to the study. Finally, the supplements and placebo will be given to the patients of each group which is determined by the tertiary investigator who is not aware of the content of the capsules.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Asthma. Condition 2: Allergic Rhinitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Familact probiotic capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment. Intervention 2: Control group: Placebo capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Rezapor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 324, 2th Eastern Rose Alley, Rose St., Villashahr 2</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166857513</zip>
        <telephone>+98 41 3333 9589</telephone>
        <email>prezapour78@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yalda Jabari Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulgasht Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165687386</zip>
        <telephone>+98 41 3382 1737</telephone>
        <email>yj_moghaddam@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All people over the age of 15, including the girl and the boy, who have allergic rhinitis.
All people over the age of 15, including boys and girls, who have asthma.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Using antibiotics in the past 4 weeks
Food allergy
Lactose intolerance
suffering from chronic diseases
Use of corticostroids
Suffering from underlying diseases other than asthma
Suffering from other kinds of rhinitis and respiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45.0</hc_code>
      <hc_code>J30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Predominantly allergic asthma</hc_keyword>
      <hc_keyword>Vasomotor and allergic rhinitis</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: Familact probiotic capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment.</i_keyword>
      <i_keyword>Control group: Placebo capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cough. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Standard Questionnaire.</prim_outcome>
      <prim_outcome>Post Nasal Drip. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Physical Examination.</prim_outcome>
      <prim_outcome>Nasal Discharge. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Physical Examination.</prim_outcome>
      <prim_outcome>Nasal polyps. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Physical Examination.</prim_outcome>
      <prim_outcome>Night snoring. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Standard questionnaire.</prim_outcome>
      <prim_outcome>Sleep disturbances. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Standard questionnaire.</prim_outcome>
      <prim_outcome>Turbinates hypertrophy. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: Physical Examination.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and 4 and 8 weeks after intervention. Method of measurement: SF-36 quality of life questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-31</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golghast Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
