<?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>IRCT20110816007350N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-30</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of a gluten free diet and a diet which contain gluten on the treatment of IBS</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between gluten-free regime and regime with gluten in symptoms of patients with IBS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In order to use the gluten free diet, the intervention group received a list of gluten free foods along with addressees of the stores which sell and distribute these foods. Individuals were fed on given diet for 12 weeks. After describing the importance of the study, the intervention group was asked to fill in the correct diet checklist and given it to the researcher at the end of the intervention. Post-test was completed after finishing the intervention and considering the interval of 4 weeks of intervention by the researcher’s assistance. Samples were also followed up with both groups until the end of the intervention. Intervention 2: Control group: The control group received an ordinary diet for 12 weeks. Patients were evacuated on signs such as pain intensity, pain duration, frequency of defecation and bloating.</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 kjkyriok</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4/111, Ramtin dead end, First Apadana Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>810656464333</zip>
        <telephone>+98 31 3266 8337</telephone>
        <email>babazadeh.s@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sina Babazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4/111, Ramtin dead end, First Apadana Street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81065646433</zip>
        <telephone>+98 31 3266 8337</telephone>
        <email>babazadeh.s@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with IBS referring to Gastroenterology Clinic of Imam Khomeini Hospital</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
The history of abdominal surgery
Patients with opioid use
Non-steroidal anti-inflammatory
Long-term antibiotic drug consumption
Kidney Failure
The presence of serious physical illnesses
Celiac disease
Diabetes
Organogenesis of the digestive system based on doing endoscopy and colonoscopy test
Fail to adherence to gluten-free diet during patient studies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome with diarrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In order to use the gluten free diet, the intervention group received a list of gluten free foods along with addressees of the stores which sell and distribute these foods. Individuals were fed on given diet for 12 weeks. After describing the importance of the study, the intervention group was asked to fill in the correct diet checklist and given it to the researcher at the end of the intervention. Post-test was completed after finishing the intervention and considering the interval of 4 weeks of intervention by the researcher’s assistance. Samples were also followed up with both groups until the end of the intervention.</i_keyword>
      <i_keyword>Control group: The control group received an ordinary diet for 12 weeks. Patients were evacuated on signs such as pain intensity, pain duration, frequency of defecation and bloating.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal pain. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Gas bowel. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Reduce the frequency of defecation. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Increase the frequency of defecation. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Constipation. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incomplete evacuation of stools. Timepoint: Patients were first assessed by Rome 3 questionnaire and weeks after the end of the treatment period based period based on symptoms they were graded from 0-3. Method of measurement: Likert scale.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-10</approval_date>
        <contact_name>Ethics committee of Ahvaz University of medical sciences</contact_name>
        <contact_address>No.4/111, Ramtin dead end, First Apadana Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
