<?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>IRCT20190914044766N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-28</date_registration>
      <primary_sponsor>High Institute for Research and Education in Transfusion Medicine</primary_sponsor>
      <public_title>Graft versus host disease prevention/reduction by microbiome and patient blood management in allogeneic hematopoietic stem cell transplant patients</public_title>
      <acronym></acronym>
      <scientific_title>Graft versus host disease prevention/reduction by microbiome and patient blood management in allogeneic hematopoietic stem cell transplant patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were randomly divided into control and intervention groups

Based on random number table
  We assign a number to each patient based on the time patients visit and perform randomization using a random number table.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: graft versus host disease. Condition 2: acute graft versus host disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group:20  Patients reported for allogeneic bone marrow transplantation: who consume one day of graft probiotic capsule daily for 21 days before transplantation until the day of transplantation./It should be noted that familact is a probiotic and prebiotic compound containing 7 strains of beneficial bacteria (Lactobacillus, Bifidobacteria and Streptococcus thermophilus) plus Prebiotic Fructoaligosaccharide). Intervention 2: Control group: 20 patients reported for allogeneic bone marrow transplantation and not taking any additional medication.</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:
Information on the main outcome is added and published

When:
The publication begins after the paper is published after the research is completed

To whom:
Information will be made available to all researchers

Conditions:
Use of published articles from this study , For more details and details, please contact the corespondent author  of the paper published in this research

Where to obtain:
Ehsan Yazdandoust
yazdandouste@gmail.com
09107434515
Corresponding author of published research articles

How to obtain:
After contacting the information provider, the information will be made available to the applicant within two weeks. This will be the posting of the information after the articles are published

Comments:
Most of the essential information was provided to the researchers by the publication of the article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Yazdandoust</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>high institute for research and education in transfusion medicine , hemmat,Next to Milad Tower</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1157-14665</zip>
        <telephone>+98 21 8860 1586</telephone>
        <email>yazdandouste@gmail.com</email>
        <affiliation>high institute for research and education in transfusion medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Yazdandoust</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>high institute for research and education in transfusion medicine, Floor 7, Quality Assurance Division</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1157-14665</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>yazdandouste@gmail.com</email>
        <affiliation>high institute for research and education in transfusion medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for allogeneic bone marrow transplant who have been referred for transplantation to Taleghani Hospital for treatment of blood malignancies
Age 20 to 50 years
The source of the transplanted tissue of all patients is peripheral blood stem cells
HLA transplanted tissue to be fully compatible with patient HLA (fully compatible with primary HLA  A , B and DR-B1 )
The prophylaxis diet should be the same to prevent GVHD
All patients use irradiated blood and products</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who did not have allogeneic bone marrow transplantation
Patient dissatisfaction
Having an infection or fever above 38.5 ° C before entering the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D89.81</hc_code>
      <hc_code>D89.810</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Graft-versus-host disease</hc_keyword>
      <hc_keyword>Acute graft-versus-host disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group:20  Patients reported for allogeneic bone marrow transplantation: who consume one day of graft probiotic capsule daily for 21 days before transplantation until the day of transplantation./It should be noted that familact is a probiotic and prebiotic compound containing 7 strains of beneficial bacteria (Lactobacillus, Bifidobacteria and Streptococcus thermophilus) plus Prebiotic Fructoaligosaccharide)</i_keyword>
      <i_keyword>Control group: 20 patients reported for allogeneic bone marrow transplantation and not taking any additional medication</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occurrence of graft-versus-host disease (GVHD). Timepoint: They are followed up clinically for up to 100 days after transplantation. Method of measurement: Using clinical evidence that occurs in the patient and the physician's opinion.</prim_outcome>
      <prim_outcome>The grade and severity of graft-versus-host disease. Timepoint: They are followed up clinically for up to 100 days after transplantation. Method of measurement: Using clinical evidence that occurs in the patient and the physician's opinion.</prim_outcome>
      <prim_outcome>The rate and percentage of regulatory T in patients. Timepoint: Day 7 and 28 after transplantation. Method of measurement: روش آزمایشگاهی فلوسایتومتری.</prim_outcome>
      <prim_outcome>Plasma levels of reg3a and ST-2. Timepoint: Day 7 and 28 after transplantation. Method of measurement: ELISA Laboratory Method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improve and reduce gastrointestinal complications. Timepoint: Up to 10 days after transplant. Method of measurement: Patient clinical statements.</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>High Institute for Research and Education in Transfusion Medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-16</approval_date>
        <contact_name>Ethics committee of High Institute for Education and Research in Transfusion Medicine</contact_name>
        <contact_address>ehran Province, Tehran, District 2, Hemmat Expy Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
