<?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>IRCT20151106024901N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-24</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53050</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple. Randomization unit: individual. Randomization tool: sealed envelope 
َThe researcher assigned individuals into two groups using lottery (selecting sealed envelopes, with a card with the letters M or C inside them), Blinding description: In this study, the patient and the researcher are kept blind. In this way, the safety and data monitoring committee know whether it is a placebo or a drug, and the researcher and the patient do not know the type of group. In this regard, the drug and the placebo will be packed in the same boxes. The drug and placebo will be packaged and delivered by the committee in separate envelopes, and the researcher will divide the patients into two groups, by giving envelope A or envelope B.</study_design>
      <phase>3</phase>
      <hc_freetext>Irritable Bowel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 500 mg mesalazine tablets 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician. Intervention 2: Control group:  received placebo 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Mehdi Rasoolimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street,University Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51666 14756</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>m_rasulimanesh@kaums.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Mehdi Rasoolimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street,University Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51666 14756</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>m_rasulimanesh@kaums.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with IBS-D according to ROME IV criteria (Loose and watery stool at at least 25% and hardy stool less than 25% of bowel movement)
Age over 18 years
Predominant symptom of diarrhea
Calprotectin levels above 50 feces
Normal colonoscopy during the last 5 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation and those who plan to become pregnant
History of major abdominal surgery other than appendectomy and cholecystectomy
A history of allergic disease such as asthma in yourself or a first-degree relative
Celiac disease
History of known psychological disease
Consumption of anti-inflammatory drugs (corticosteroids, NSAIDs), mast cell stabilizers and antibiotics in the last 3 months
History of inflammatory bowel disease or ulcerative colitisSensitivity to sulfur-containing compounds such as mesalazine
Consumption of lactulose and recent probiotics
Evidence of organic disease in colonoscopy
Normal stool calprotectin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome</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: 500 mg mesalazine tablets 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician.</i_keyword>
      <i_keyword>Control group:  received placebo 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal pain. Timepoint: Before and 8 weeks after the intervention. Method of measurement: visual analog scale (0=no pain; 10= worst pain).</prim_outcome>
      <prim_outcome>Bloating. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on a questionnaire.</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on the prepared questionnaire, the number of diarrhea per day will be measured.</prim_outcome>
      <prim_outcome>Consumption of mesalazine. Timepoint: Before and 8 weeks after the intervention. Method of measurement: Based on a questionnaire.</prim_outcome>
      <prim_outcome>Fecal calprotectin levels. Timepoint: Before and 8 weeks after the intervention. Method of measurement: ELISA method with laboratory kit (calprest).</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>2020-11-09</approval_date>
        <contact_name>Ethics committee of tabriz University of Medical Sciences</contact_name>
        <contact_address>Imam Reza Hospital, Golgasht St., Daneshgah St., Tabriz, East Azerbaijan Province tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
