<?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>IRCT20240105060622N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>comparing the effect of probiotics in cystic fibrosis</public_title>
      <acronym></acronym>
      <scientific_title>comparing the effect of probiotics in improving pulmonary gastrointestinal symptoms with cystic fibrosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74849</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the patients visiting the Cystic Fibrosis Clinic of the Children's Medical Center, 108 patients between the ages of 6 and 12 will be randomized into two groups: probiotic (case) and placebo (control).Blocking was done individually and in blocks of 10 in the form of 5 cases and 5 controls, And in order to hide the direction of the block, they will be allocated to two groups of cases and controls using the https://www.sealedenvelope.com/ system with a ratio of 1:1, Blinding description: Each Roteflor sachet contains 800 million active lyophilized cells of Lactobacillus roteri. Placebo is also made by Frabiotic similar to the main drug and provided to the researcher.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cystic Fibrosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the probiotic group will receive Lactobacillus reuteri (Rotflor) at the rate of 10*8 CFU/d for one month. Intervention 2: Control group: Patients receive a placebo.</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:
Data can potentially be shared after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
The data will be available to researchers working in academic and scientific institutions and people working in industry

Conditions:
Unlimited

Where to obtain:
dr mehri ayati.09126148071.dr.m.ayati61@gmail.com

How to obtain:
First, a clear request should be given by official email, the reason for the data request should be stated and the work to be done to the end.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehri Ayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Medical Center Hospital, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 21 6147 9000</telephone>
        <email>dr.m.ayati61@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mehri Ayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Children's Medical Center Hospital, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St.,Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733151</zip>
        <telephone>+98 912 614 8071</telephone>
        <email>dr.m.ayati61@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>cystic fibrosis patient with an age range of 6 to 12 years
Informed consent from parents
Having pancreatic insufficiency
Fecal elastase less than 200 micrograms per gram</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having comorbidity disease except cystic fibrosis
contraindication for probitotics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cystic fibrosis</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>Intervention group: Patients in the probiotic group will receive Lactobacillus reuteri (Rotflor) at the rate of 10*8 CFU/d for one month.</i_keyword>
      <i_keyword>Control group: Patients receive a placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fat stool. Timepoint: Measurement of fat excretion at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-stool Exam.</prim_outcome>
      <prim_outcome>Patient Weight. Timepoint: Measurement of the patient's weight at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: scales.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Measurement of the quality of life at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Questionnaire-Clinical File.</prim_outcome>
      <prim_outcome>Forced Expiratory Volume in First Second (FEV1). Timepoint: Measurement of the FEV1 at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.</prim_outcome>
      <prim_outcome>Forced Vital Capacity (FVC). Timepoint: Measurement of the FVC at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.</prim_outcome>
      <prim_outcome>Throat culture. Timepoint: Measurement of the Throat culture at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-Throat culture test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-19</approval_date>
        <contact_name>Research Ethics Committees, Research Ethics Committee of Children’s Medical Center- Tehran Universit</contact_name>
        <contact_address>Children’s Medical Center, Gharib st, Keshavarz blv, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
