<?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>IRCT20100524004010N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Bacillus coagulans and inulin compared with low FODMAP diet in treatment of IBS</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of synbiotic supplements containing Bacillus coagulans and inulin with low FODMAP diet compared with low FODMAP diet alone on inflammatory factors, clinical outcomes and quality of life in patients with irritable bowel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method use 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable Bowel Syndrom.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: will receive one synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day plus low FODMAP diet for 8 weeks. Intervention 2: Control group: will receive  low FODMAP diet and placebo (starch) for 8 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because the participant’s informations should remain confidental.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azita Hekmatdoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West arghavan, Sanaat square, Farahzadi boulvard, Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00</zip>
        <telephone>+98 912 306 5084</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>West arghavan, Sanaat square, Farahzadi boulvard, Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00</zip>
        <telephone>+98 912 306 5084</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>18-65 years
Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria (1.Improvement with defecation 2.Onset associated with a change in stool frequency  3.Onset associated with a change in stool form (appearance)  At least three days a month, three months a year and no pathological findings in the clinical investigating)
lack of any organic intestinal disease(diagnosed by  last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture).
No medical history of chronic gastrointestinal and colorectal disease
Absence of any major bowel surgery
Absence of regular use of laxatives or antidiarrheal drugs
No chronic use of antibiotics, 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, heparin,…
No history of breast cancer in patient or in first-degree relatives of a person
Absence of severe mental or behavioral disorder
Absence of nicotine and its derivatives use in last 6 monthsNo usage of NSAIDs and aspirin in last week(influence on gut permeability)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Life threatening symptoms
Death
Not agree to continue 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 receive one synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day plus low FODMAP diet for 8 weeks</i_keyword>
      <i_keyword>Control group: will receive  low FODMAP diet and placebo (starch) for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal pain intensity. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Abdominal pain frequency. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Abdominal distension. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Satisfaction with bowel habits. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Interference with community function. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Defecation frequency. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
      <prim_outcome>Defecation consistency. Timepoint: Beginning and end of study. Method of measurement: Questionaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient-rated Severity score. Timepoint: Begining and end of the study. Method of measurement: Questionare.</sec_outcome>
      <sec_outcome>IBS-SSS. Timepoint: Begining and end of the study. Method of measurement: Questionare.</sec_outcome>
      <sec_outcome>IL-6. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit.</sec_outcome>
      <sec_outcome>INF-ɣ. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit.</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>2017-12-31</approval_date>
        <contact_name>National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci</contact_name>
        <contact_address>West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
