<?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>IRCT201204199510N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Wheat oral desensitization in patient with wheat allergy</public_title>
      <acronym>Wheat Oral Immunotherapy</acronym>
      <scientific_title>Evaluation of efficacy and safety of wheat oral immunotherapy in patient with wheat allergy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: wheat allergy. Condition 2: Desensitization.</hc_freetext>
      <i_freetext>The anaphylactic patients take Loratadine and Montelukast, three days prior to admission to prevent the severe adverse reaction. On the first day of admission; we perform OFC again with premedication, so we determine the initial dose of rush OIT.  In rush phase, patients take bread two time a day, and if they can take them without severe reactions, they are asked to take bread with 50% increase of the former dose. Maximum amount of bread is set at 52 g of bread. In outpatient method after the OFC, the patients are asked to ingest a small amount of wheat at home every day. The initial protein dose is about 1/4 of the threshold to elicit positive symptoms in OFC without premedication. Amount of wheat ingestion gradually buildup to 52 g of bread that contain 5.2g of wheat protein according to their symptoms. In both groups after completion of build-up phase, the patients are asked to ingest 52 g of bread containing 5.2 g wheat protein as a maintenance dose "daily" for 3 months. During this period the patients should continue the wheat-elimination diet. َََAt the end of maintenance phase we performed OFC with 52 g of bread (containing 5.2 g wheat protein). If the patients could pass the test, we regarded them as desensitized, and after that they could ingest wheat products without any restrictions. The patients who completed treatment had to eat at least 5.2 g wheat protein every day since we were not sure whether they have got tolerance or not. Moreover it is not difficult for most of people to eat 5.2 g wheat protein per day, because they usually have the same amount of wheat products in their daily diet..</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>Alireza Khayatzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of  Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6147 2153</telephone>
        <email>a-khayatzadeh@razi.tums.ac.ir</email>
        <affiliation>Department of Allergy and Clinical Immunology in Children's Medical Center at Tehran University of M</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Movahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children' Medical Center, Dr.Gharib st, Keshavarz Blvd, Tehran 14194, I.R. of  Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6147 2153</telephone>
        <email>movahedm@sina.tums.ac.ir</email>
        <affiliation>Department of Allergy and Clinical Immunology of Children's Medical Center at Tehran University of M</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients above 5 years with IgE mediated wheat allergy (positive skin prick test response to wheat flour and wheat specific IgE level above 0.35 IU/L); positive oral food challenge to wheat.&#13;
exclusion criteria: severe and uncontrolled asthma; chronic urticaria; significant systemic disease; poor compliance</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T78</hc_code>
      <hc_code>Z51.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adverse effects, not elsewhere classified</hc_keyword>
      <hc_keyword>Desensitization to allergens</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The anaphylactic patients take Loratadine and Montelukast, three days prior to admission to prevent the severe adverse reaction. On the first day of admission; we perform OFC again with premedication, so we determine the initial dose of rush OIT.  In rush phase, patients take bread two time a day, and if they can take them without severe reactions, they are asked to take bread with 50% increase of the former dose. Maximum amount of bread is set at 52 g of bread. In outpatient method after the OFC, the patients are asked to ingest a small amount of wheat at home every day. The initial protein dose is about 1/4 of the threshold to elicit positive symptoms in OFC without premedication. Amount of wheat ingestion gradually buildup to 52 g of bread that contain 5.2g of wheat protein according to their symptoms. In both groups after completion of build-up phase, the patients are asked to ingest 52 g of bread containing 5.2 g wheat protein as a maintenance dose "daily" for 3 months. During this period the patients should continue the wheat-elimination diet. َََAt the end of maintenance phase we performed OFC with 52 g of bread (containing 5.2 g wheat protein). If the patients could pass the test, we regarded them as desensitized, and after that they could ingest wheat products without any restrictions. The patients who completed treatment had to eat at least 5.2 g wheat protein every day since we were not sure whether they have got tolerance or not. Moreover it is not difficult for most of people to eat 5.2 g wheat protein per day, because they usually have the same amount of wheat products in their daily diet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Daily consumption of wheat products without any complications. Timepoint: Before oral immunotherapy and 3 month after starting maintenance phase. Method of measurement: Oral food challenge with 52 gr of bread containing 5.2 g wheat protein.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation of skin, respiratory, gastrointestinal symptoms and anaphylaxis reaction during course of treatment. Timepoint: During buildup and maintenance phase. Method of measurement: Number of participants with adverse events  and observation of their sign and symptoms.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-31</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Office of TUMS Public Relations, sixth Floor,Ghods street, Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
