<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822624</url>
  </required_header>
  <id_info>
    <org_study_id>ATOP/PRO-2</org_study_id>
    <nct_id>NCT03822624</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis</brief_title>
  <official_title>Randomized, Double Blind, Placebo Controlled Study to Evaluate Efficiency and Safety on the Use of a Probiotic in SCORAD Reduction in 4-to-17 Years-old Patients With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biopolis S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korott, S.L.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Biopolis S.L.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study's objective is to confirm that an oral probiotic treatment reduces the signs and&#xD;
      symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years,&#xD;
      as compared to placebo. It will also be examined if the probiotic treatment, as compared to&#xD;
      placebo, reduces the quantity of topical steroids used to treat disease flares, and increases&#xD;
      the time till the first disease flare after the end of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the SCORAD index at 12 weeks.</measure>
    <time_frame>12-week</time_frame>
    <description>SCORAD: SCOring of Atopic Dermatitis&#xD;
Subscales:&#xD;
Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20&#xD;
Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days that each patient requires the administration of topical corticosteroids.</measure>
    <time_frame>12-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days that each patient requires the administration of topical corticosteroids in disease flares.</measure>
    <time_frame>12-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dose of topical corticosteroids.</measure>
    <time_frame>12-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who reach a CGI score lower than 2.</measure>
    <time_frame>12-week</time_frame>
    <description>CGI: Clinical Global Impression&#xD;
Total: 0 - 5 (Higher values represent a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events.</measure>
    <time_frame>12-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of antihistamines and other treatments.</measure>
    <time_frame>12-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the treatment.</measure>
    <time_frame>12-week</time_frame>
    <description>Percentage of treatment intake days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free time up to 24 weeks.</measure>
    <time_frame>24-week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Probiotic mixture with three bacterial strains with maltodextrin as a carrier.</description>
    <arm_group_label>Probiotic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator with maltodextrin as a carrier.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 4 to 17 years, both inclusive.&#xD;
&#xD;
          -  Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria.&#xD;
&#xD;
          -  SCORAD index of 20-40, both inclusive.&#xD;
&#xD;
          -  Patients whose parents or legal guardian sign the informed consent.&#xD;
&#xD;
          -  The minor over 12 years must also give their consent to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Breast feeding.&#xD;
&#xD;
          -  Women of childbearing age who, in the opinion of the investigator, do not commit to&#xD;
             using an effective method of contraception, if they have an active sex life or start&#xD;
             during the trial.&#xD;
&#xD;
          -  Treated with phototherapy for the atopic dermatitis in the previous 2 months.&#xD;
&#xD;
          -  Treated with systemic corticosteroids in the previous 2 months or need for&#xD;
             corticosteroids anticipated during the first 12 weeks of the study.&#xD;
&#xD;
          -  Having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or&#xD;
             having an anticipated need for cytotoxic or immunosuppressive therapy during the first&#xD;
             12 weeks of the study.&#xD;
&#xD;
          -  Treated with probiotics in the previous two months.&#xD;
&#xD;
          -  Treated with systemic antibiotics in the previous four days.&#xD;
&#xD;
          -  Patients with a fever (temperature &gt; 37.5°C, axillary or equivalent).&#xD;
&#xD;
          -  Serious allergic diseases.&#xD;
&#xD;
          -  Diseases related to immunodeficiency processes or cancer.&#xD;
&#xD;
          -  Other skin diseases that can make assessment of the atopic dermatitis difficult or&#xD;
             which require the continuous use of topical corticosteroids.&#xD;
&#xD;
          -  Patients in whom any of the study products is contraindicated according to its summary&#xD;
             of product characteristics.&#xD;
&#xD;
          -  Patients who have participated in research studies with medicinal products during the&#xD;
             previous 3 months.&#xD;
&#xD;
          -  Patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn's&#xD;
             disease or ulcerative colitis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>María Empar Chenoll, PhD</last_name>
    <phone>625851114</phone>
    <email>maria.chenoll@adm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Quirónsalud San José</name>
      <address>
        <city>Madrid</city>
        <zip>28002</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Vithas Nisa 9 de Octubre</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822624
org study id: ATOP/PRO-2
nct id: NCT03822624
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study's objective is to confirm that an oral probiotic treatment reduces the signs and
      symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years,
      as compared to placebo. It will also be examined if the probiotic treatment, as compared to
      placebo, reduces the quantity of topical steroids used to treat disease flares, and increases
      the time till the first disease flare after the end of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-blind
measure: Change from baseline in the SCORAD index at 12 weeks.
time frame: 12-week
description: SCORAD: SCOring of Atopic Dermatitis
Subscales:
Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20
Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
measure: Number of days that each patient requires the administration of topical corticosteroids.
time frame: 12-week
measure: Number of days that each patient requires the administration of topical corticosteroids in disease flares.
time frame: 12-week
measure: Total dose of topical corticosteroids.
time frame: 12-week
measure: Number of patients who reach a CGI score lower than 2.
time frame: 12-week
description: CGI: Clinical Global Impression
Total: 0 - 5 (Higher values represent a worse outcome)
measure: Number of adverse events.
time frame: 12-week
measure: Use of antihistamines and other treatments.
time frame: 12-week
measure: Adherence to the treatment.
time frame: 12-week
description: Percentage of treatment intake days.
measure: Disease-free time up to 24 weeks.
time frame: 24-week
arm group label: Probiotic group
arm group type: Experimental
arm group label: Placebo group
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Probiotic
description: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
arm group label: Probiotic group
intervention type: Other
intervention name: Placebo
description: Placebo comparator with maltodextrin as a carrier.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: María Empar Chenoll, PhD
phone: 625851114
email: maria.chenoll@adm.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Spain
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema