<?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>IRCT20201125049491N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of daily consumption of probiotic yogurt on albumin to creatinine Ratio, eGFR and metabolic parameters in type 2 diabetic patients with microalbuminuria</public_title>
      <acronym></acronym>
      <scientific_title>The effect of daily consumption of probiotic yogurt on albumin to creatinine Ratio, eGFR and metabolic parameters in type 2 diabetic patients with microalbuminuria</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52623</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each person is assigned a code and this code is entered into Excel software, and then used to randomize the rand function of Excel software, Blinding description: The shape, appearance, packaging, color and smell of both probiotic and non-probiotic yogurts will be quite similar. In addition, the person who provides yogurts to patients is aware of the type of yogurt, but the researcher and the patient are not aware of it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic nephropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will receive 300g of probiotic yogurt(Haraz Company) enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 8 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g. Intervention 2: Control group: Control group: 300g will receive normal yogurt from Haraz company 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mojtaba Ghoreishy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3913883361</zip>
        <telephone>+98 86 4222 8244</telephone>
        <email>seyed.mojtaba.ghoreishy@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mojtaba Ghoreishy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3913883361</zip>
        <telephone>+98 86 4222 8244</telephone>
        <email>seyed.mojtaba.ghoreishy@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic nephropathy with microalbuminuria  (Albumin to creatinine ratio 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2)
Has an age of 80-20 years
BMI less than 40 kg / m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy
Smoking, alcohol and tobacco
History of taking antibiotics and NSAIDS (during the last month)
Take omega 3 supplements and vitamins E and C during the last three months
Consumption of probiotic supplements or foods containing probiotics during the last three months
Lactose intolerance
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic nephropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: They will receive 300g of probiotic yogurt(Haraz Company) enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 8 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g.</i_keyword>
      <i_keyword>Control group: Control group: 300g will receive normal yogurt from Haraz company for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Albumin to creatinine ratio. Timepoint: First the intervention and 8 weeks later at the end of the intervention. Method of measurement: Laboratory kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>EGFR. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>TG. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>TC. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>LDL. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>HDL. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>FBS. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>HbA1c. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory kit.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: At the beginning of the intervention and 8 weeks later at the end of the intervention. Method of measurement: Special laboratory 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>Diabetes Research Center, Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-19</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>First Floor, Faculty of Medicine, Building No. 1, North Door of the University, POURSINA St, GHODS St, ENGHELAB St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
