<?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>IRCT20211108053007N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67104</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign women, stratified block randomization method is used based on BMI, the use of hormonal drugs that regulate the menstrual cycle, and metformin, Blinding description: Placebo sachets are completely similar in appearance to synbiotic sachets. In order to carry out this research in a three-blind manner, at the time of the start of the study, the set of sachets containing synbiotic or placebo supplements are coded as A and B by the factory so that the researcher, statistical analyst and patients are not informed about the type of supplements received by each group.</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For 12 weeks, they will receive daily one 2 gram sachet of synbiotic containing 10 to the power of 11 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g Lactobacillus rhamnus, 10 to the power of 10 CFU/g Lactobacillus heloticus, 500 mg fructo-oligosaccharide and 0.7% orange flavor. Intervention 2: Control group:  They will receive a placebo sachet daily containing 2 grams of starch and 0.7% orange flavoring.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as the main results, will be shared.

When:
The beginning of the access period is 12 months after the publication of the results

To whom:
It will be available for researchers working in academic and scientific institutions and industry.

Conditions:
The documentation can only be used for more complete studies in this field.

Where to obtain:
Zahra Hariri

How to obtain:
Communication will be possible through the email given in the previous section

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Hariri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998743664</zip>
        <telephone>+98 21 2676 4689</telephone>
        <email>nutrition@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Hariri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998743664</zip>
        <telephone>002126764689</telephone>
        <email>hariri.nut@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
At least 2 weeks have passed since the diagnosis and treatment of PCOS
Being in the age range of 18-45 years
Being in the BMI range of 18.5-35
Willingness to cooperate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy
Having liver diseases, kidney failure and heart failure, infectious or inflammatory diseases, thyroid gland disorders, diabetes, types of cancer and hyperprolactinemia.
Consuming supplements or products containing synbiotics or probiotics in the last month
Adherence to special diets or weight loss diets during the last three months
Taking corticosteroids or omega-3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian 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: For 12 weeks, they will receive daily one 2 gram sachet of synbiotic containing 10 to the power of 11 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g Lactobacillus rhamnus, 10 to the power of 10 CFU/g Lactobacillus heloticus, 500 mg fructo-oligosaccharide and 0.7% orange flavor.</i_keyword>
      <i_keyword>Control group:  They will receive a placebo sachet daily containing 2 grams of starch and 0.7% orange flavoring.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.</prim_outcome>
      <prim_outcome>Hirsotism domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.</prim_outcome>
      <prim_outcome>Weight domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.</prim_outcome>
      <prim_outcome>Infertility Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.</prim_outcome>
      <prim_outcome>Menstrual Problems domain score of PCOSQ-26. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PCOSQ-26 form.</prim_outcome>
      <prim_outcome>Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.</prim_outcome>
      <prim_outcome>Physical functioning score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: SF-12 form.</prim_outcome>
      <prim_outcome>Perceived Stress scale (PSS-10) score. Timepoint: At the beginning and 12 weeks after the start of the intervention. Method of measurement: PSS-10 form.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-12</approval_date>
        <contact_name>Research Ethics Committees of vice-chancellor in Research Affairs - Shahd Beheshti University of Med</contact_name>
        <contact_address>Ground floor, Building No. 2, Aarabi St,. Daneshjoo Blvd., Yaman St., Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
