<?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>IRCT201405181597N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-16</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Effect of Probiotics on diabetes mellitus arising in pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Probiotics in comparison with placebo on glucose metabolism, weight changes and inflammatory and oxidative stress indices in women with gestational diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will be randomly included in intervention and control groups through sequential matching based on pre-pregnancy body mass index (18.5 to 24.9, 25 to 29.9 and 30 and more kilograms per square meter) and fasting plasma glucose (92 to 104 and 105 and more milligrams per deciliter).</study_design>
      <phase>2</phase>
      <hc_freetext>Gestational Diabetes Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Control: in control group, 32 pregnant women after the entry qualifications, will take one tablet of placebo with the shape and color exactly similar to 4biocap for 8 weeks and variables will be analyzed before and after the intervention. Intervention 2: Intervention: in intervention group, 32 pregnant women after the entry qualifications will take one capsule of 4biocapⓇ containing 180 mg(&gt;1 billion CFU) of a standardized, cream colored powder consisting of freeze-dried cultures of: Lactobacillus Acidophilus LA-5Ⓡ, Bifidobacterium, BB-12Ⓡ, Streptococcus Thermophilus, STY-31 and Lactobacillus Delbrueckii ssp. Bulgaricus, LBY-27, once a day for 8 weeks and variables will be analysed before and after the intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Dolatkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>International Branch, 19, Shahid Abbaspour St., Vali-Asr Ave., Teharn, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 218820902021</telephone>
        <email>neda_dolatkhah@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Majid Hajifaraji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition &amp; Food Technology, 3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21223606612</telephone>
        <email>m39faraji@yahoo.com; m.hajifaraji@nnftri.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: nulliparity; diagnosis of gestational diabetes mellitus between 24 weeks and 0 days and 28 weeks and 6 days of pregnancy with oral screening test; fasting blood glucose level between 92- 126 mg/dl; body mass index 18.5 and more; nulliparity; negative history of f diabetes mellitus before the current pregnancy; chronic diseases; Smoking and/or alcohol consumption; probiotic food products consumption through current 2 weeks; antibiotic usage through current month; acute GI condition through current month and glucocorticoid and immunosuppressor drugs usage Exclusion criteria: need for insulin or other hypoglycemic drugs; corticosteroids or immune-suppressants usage or acute GI condition during the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus arising in pregnancy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control: in control group, 32 pregnant women after the entry qualifications, will take one tablet of placebo with the shape and color exactly similar to 4biocap for 8 weeks and variables will be analyzed before and after the intervention.</i_keyword>
      <i_keyword>Intervention: in intervention group, 32 pregnant women after the entry qualifications will take one capsule of 4biocapⓇ containing 180 mg(&gt;1 billion CFU) of a standardized, cream colored powder consisting of freeze-dried cultures of: Lactobacillus Acidophilus LA-5Ⓡ, Bifidobacterium, BB-12Ⓡ, Streptococcus Thermophilus, STY-31 and Lactobacillus Delbrueckii ssp. Bulgaricus, LBY-27, once a day for 8 weeks and variables will be analysed before and after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting Blood Glucose. Timepoint: Before and after intervention. Method of measurement: Enzymatic.</prim_outcome>
      <prim_outcome>Fasting Plasma Insulin. Timepoint: Before and after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Homeostatic Model Assessment/HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Calculation.</prim_outcome>
      <prim_outcome>Quantitative Insulin Sensitivity Check/QUICKI-index. Timepoint: Before and after intervention. Method of measurement: Calculation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Highly Sensitive-C Reactive Protein/hs-CRP. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Tumor Necrozing Factor Alpha/TNF-α. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Interleukine-6. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Toatal Antioxidant Capacity/TAC. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Malondialdehyde/MDA. Timepoint: Before and after intervention. Method of measurement: Enzymatic.</sec_outcome>
      <sec_outcome>Glutathione Reductase/GSH-Red. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Superoxide Dismutase/SOD. Timepoint: Before and after intervention. Method of measurement: Elisa.</sec_outcome>
      <sec_outcome>Glutathione Peroxidase/GSH-Px. Timepoint: Before and after intervention. Method of measurement: Enzymatic.</sec_outcome>
      <sec_outcome>Uric Acid. Timepoint: Before and after intervention. Method of measurement: Enzymatic.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before, 2 weeks, 4 weeks, 6 weeks and 8 weeks after intervention. Method of measurement: Digital scale.</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 and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-18</approval_date>
        <contact_name>The International Branch of Shahid Beheshti University of Medical Sciences and Health Services</contact_name>
        <contact_address>19, Shahid Abbasspour St., Vali-Asr Ave., Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
