<?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>IRCT20140623018206N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-14</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Familact synbiotic in treatment of community acquired pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Familact synbiotic on the outcomes of the patients with community acquired pneumonia (clinical improvement, laboratory and complications)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45021</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups using a random number table. In this way, first in Excel software, we create a variable from 1 to 130 (instead of 130, the total sample size). Then we create another variable in another column and generate 65 random numbers one and 65 random numbers two with the randomization command. The numbers of one are intervention group and the numbers of two groups are our placebo group, Blinding description: The study is double-blind. The patient and the executor (student) are not aware of the type of treatment each person receives. The tablets are designed in the same shape and in the same shape as the cans. Numbers 1 to 130 are written on dark envelopes and type A or B is placed inside the envelope. Envelopes are such that they will not be visible from the outside. In order, each person who opens the envelope will be opened in order and based on the A or B treatment, a can of A or B tablets will be given to the patient along with an explanation of how to use it.</study_design>
      <phase>3</phase>
      <hc_freetext>community acquired pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Familact capsule (once daily) for 10 days along with antibiotics. Familact® is a synbiotic compound (probiotic + prebiotic) and it contains high amounts of 9 beneficial and safe bacterial strains along with fructooligosaccharide as a prebiotic. The strains and prebiotics used in this product include the following: Lactobacillus rhamnosus, bifidobacterium lactis, Lactobacillus casei, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium langum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus. Intervention 2: Control group: Only antibiotics.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Ebrahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical sciences, Ghaffari Street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9718797187</zip>
        <telephone>+98 56 1444 8671</telephone>
        <email>a.ebrahimzadeh@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Ebrahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences, Ghaffari Street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9718797187</zip>
        <telephone>+98 56 1444 7186</telephone>
        <email>a.ebrahimzadeh@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years old with community-acquired pneumonia diagnosed by an infectious disease specialist and requiring hospitalization (based on CURB-65 criteria)
Patients with the same epidemiological factors (age, gender, and underlying disease) and possible microorganisms
Patients who need one type of treatment and do not need to other treatment such as steroids</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have taken antibiotics 48 hours before hospitalization
Patients with immunodeficiency (HIV, receiving immunosuppressive drugs, transplantation, chemotherapy, acute pancreatitis), pregnant and lactating women
Patients who have consumed probiotics, prebiotics and synbiotics in the past month
Patients who have not consented</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumonia due to Streptococcus pneumoniae</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: Familact capsule (once daily) for 10 days along with antibiotics. Familact® is a synbiotic compound (probiotic + prebiotic) and it contains high amounts of 9 beneficial and safe bacterial strains along with fructooligosaccharide as a prebiotic. The strains and prebiotics used in this product include the following: Lactobacillus rhamnosus, bifidobacterium lactis, Lactobacillus casei, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium langum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus.</i_keyword>
      <i_keyword>Control group: Only antibiotics</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: At first, after 72 hours, and at the end of hospitalization. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: At first, after 72 hours, and at the end of hospitalization. Method of measurement: Respiratory Rate per minute.</prim_outcome>
      <prim_outcome>White blood cells. Timepoint: After 72 hours of  hospitalization. Method of measurement: Laboratory test.</prim_outcome>
      <prim_outcome>Erythrocyte sedimentation rate. Timepoint: At first, and at the end of hospitalization. Method of measurement: Laboratory test.</prim_outcome>
      <prim_outcome>C-Reactive Protein. Timepoint: At first, and at the end of hospitalization. Method of measurement: Laboratory test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications of pneumonia. Timepoint: At the end of study. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: During the study. Method of measurement: Questionnaire.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-30</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences, Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
