<?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>IRCT20220425054653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of probiotic supplementation on obesity</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effects of Probiotic supplementation on body mass index in overweight and obese adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64371</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It will be done with simple random method using the lottery. For each patient, a number or code is provided, then the numbers will be written on pieces of paper. The pieces of paper are placed in a container and well stirred, and the sample is selected according to the sample size, Blinding description: Prior to the beginning of the study, the canisters containing the capsules are coded by individuals other than the research team, A and B, so that the knowledge of the type of capsules received by each group is not known to the researcher. Since this study is double blind, the subjects , the researchers have no information about the individuals located in the studied and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Overweight and Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Daily intake of a probiotic capsule containing (Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, Bifidobacterium brouh, Bifidobacterium longum, Bifidobacterium bifidum, Streptococcus thermophilus,10^9 cfu), for 12 week, Production company: Danesh Bonyan Zist Takhmir. Intervention 2: Control group: A daily placebo capsule with appearance characteristics including shape, color, smell, and taste completely similar to a probiotic capsule without microorganisms, for 12 weeks, Production company: Danesh Bonyan Zist Takhmir.</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 Due to ethical issues</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abolghassem Jazayery</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>End of Shahid Sattari Highway - University Square - Shahadai Hesarak Boulevard - Islamic Azad University Science and Research Branch</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۷۷۸۹۳۸۵۵</zip>
        <telephone>+98 21 4486 1815</telephone>
        <email>djazayery@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR.Abolghassem Jazayery</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>End of Shahid Sattari Highway - University Square - Shahadai Hesarak Boulevard - Islamic Azad University Science and Research Branch</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۷۷۸۹۳۸۵۵</zip>
        <telephone>+98 21 4486 1815</telephone>
        <email>djazayery@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 18 to 60 years
Body mass index more than 25 kg/m2
full person's willingness to cooperate in the project</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an acute or chronic metabolic disorder
Pregnancy, lactation, Menopause
Having a Weight loss diet in the last two months
Intake of antibiotic</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</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: Daily intake of a probiotic capsule containing (Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, Bifidobacterium brouh, Bifidobacterium longum, Bifidobacterium bifidum, Streptococcus thermophilus,10^9 cfu), for 12 week, Production company: Danesh Bonyan Zist Takhmir</i_keyword>
      <i_keyword>Control group: A daily placebo capsule with appearance characteristics including shape, color, smell, and taste completely similar to a probiotic capsule without microorganisms, for 12 weeks, Production company: Danesh Bonyan Zist Takhmir</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Mass Index. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Calculated (Divide the weight in kilograms by the square of the height in meters).</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Weight of the participants with minimal clothing and without shoes using a Seca scale.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Tape measure.</prim_outcome>
      <prim_outcome>Hip circumference. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Tape measure.</prim_outcome>
      <prim_outcome>Waist to hip ratio. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Calculate waist circumference divided by hip circumference.</prim_outcome>
      <prim_outcome>Body fat. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Using the  Deurenberg equation.</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>danesh bonyan zist tahkmir</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-21</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University-Science and Research Branch</contact_name>
        <contact_address>End of Shahid Sattari Highway - University Square - Shahadai Hesarak Boulevard - Islamic Azad University Science and Research Branch Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
