<?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>IRCT20100524004010N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of glutamine  on clinical outcomes, quality of life and intestinal permeability in patients with irritable bowel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides and Polyols) diet with glutamine supplement versus placebo on clinical outcomes, quality of life and intestinal permeability in patients with irritable bowel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46426</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method used in this study to create a randomization
process is simple randomization, so we utilize random
number table. Beginning of the study, each person is
randomly assigned to one of the 2 study groups
according to the randomized distribution table, Blinding description: In this study, patients will receive a supplement or placebo with a low fodmap diet for 6 weeks depending on the group they are in. Patients in the supplement group will receive L-glutamine powder, and the placebo group will receive the iso whey protein powder which is similar in shape and color to the supplement. 5 g three times daily in 230 ml of water.
Before starting the study,  powdered cans are coded by a person other than the researcher into group A and group B to the purpose of not informing the researcher of the type of powder used by each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: will receive15 g (5 grams three times a day) L- glutamine supplement plus low FODMAP diet for 6 weeks. Intervention 2: Control group: will receive 15 g (5 grams three times a day) iso whey supplement plus low FODMAP diet for 6 weeks.</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 there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azita Hekmatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Arghavan, Shahrak Gharb</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2293 0824</telephone>
        <email>a_hekmat2000@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Hekmatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 2293 0824</telephone>
        <email>a_hekmat2000@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with irritable bowel syndrome, according to a gastroenterologist diagnosed according to ROME IV criteria (having at least one day a week over the past 3 months for at least two of the following: 1- related to Defecation; 2- related to the frequency of defecation, 3- related to changes in stool shape and consistency, and no pathological findings in gastrointestinal
Body Mass Index in range (18-25)
Lack of any organic intestinal disease ( diagnosed by last 5 years ago colonoscopy) and intestinal infection (diagnosed by stool culture)
Lack of medical history of chronic gastrointestinal and colorectal disease
Lack of any major bowel surgery
Lack of medical history of liver disorders
Absence of regular use of laxatives or antidiarrheal drugs
No chronic use of corticosteroids and immunosuppressants
No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate
No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin and heparin
Absence of nicotine and its derivatives use in the last 6 months
No usage of NSAIDs and aspirin in last week (influence on gut permeability)
Absence of severe mental or behavioral disorder
Lack of medical history of kidney disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not agree to entering the study
Consumption of artificial sweeteners (effect on intestinal permeability)  2 days before entering the study</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: will receive15 g (5 grams three times a day) L- glutamine supplement plus low FODMAP diet for 6 weeks</i_keyword>
      <i_keyword>Control group: will receive 15 g (5 grams three times a day) iso whey supplement plus low FODMAP diet for 6 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Irritable Bowel Syndrome symptom severity score. Timepoint: Beginning and end of study. Method of measurement: Irritable Bowel Syndrome symptom severity scale Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Beginning and end of study. Method of measurement: Irritable bowel syndrome quality of life Questionnaire.</sec_outcome>
      <sec_outcome>Serum zonulin. Timepoint: Beginning and end of the study. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Abdominal pain intensity. Timepoint: Beginning and end of the study. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Abdominal pain frequency. Timepoint: Beginning and end of the study. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Abdominal distension. Timepoint: Beginning and end of the study. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Satisfaction with bowel habits. Timepoint: Beginning and end of the study. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Interference with community function. Timepoint: Beginning and end of the study. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Defecation frequency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Defecation consistency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-04</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
