xml: <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/NCT05989295</url>
    </required_header>
    <id_info>
      <org_study_id>WK2023002</org_study_id>
      <nct_id>NCT05989295</nct_id>
    </id_info>
    <brief_title>A Probiotic That Reduces Atopic Skin</brief_title>
    <official_title>The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wecare Probiotics Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Methodex</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Wecare Probiotics Co., Ltd.</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>
        To assess the efficacy and safety of the use of probiotics as food supplements in reducing&#xD;
        the SCORAD index in children with atopic skin compared with placebo. This is a randomized,&#xD;
        placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32&#xD;
        patients who attend some of the research centers. Patients will be randomized into one of the&#xD;
        2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05)&#xD;
        and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12&#xD;
        weeks, the days of use of topical corticosteroids and one valuations of the skin condition&#xD;
        (hydration).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 26, 2022</start_date>
    <completion_date type="Actual">April 21, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the outbreaks of atopic skin</measure>
      <time_frame>12 weeks</time_frame>
      <description>use the SCORAD index to measure the outbreaks of atopic skin</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Atopic Skin</condition>
    <condition>Children</condition>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>2.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>(2B CFU/sachet) Lactobacillus rhamnosus LRa05 and maltodextrin Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>probiotic LRa05</intervention_name>
      <description>treatment about 12 weeks</description>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_label>Probiotic group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index&#xD;
               (16-40).&#xD;
  &#xD;
            2. Patients aged 2-14 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients intolerant to gluten, lactose or cow's milk protein.&#xD;
  &#xD;
            -  Patients who change the type of diet during the study to improve their atopic&#xD;
               dermatitis.&#xD;
  &#xD;
            -  Patients with atopic dermatitis in remission phase (absence of sprouts and with SCORAD&#xD;
               index = 0).&#xD;
  &#xD;
            -  Patients with an allergy or intolerance to any of the ingredients in the formulation&#xD;
               of the product under study.&#xD;
  &#xD;
            -  Patients taking immunomodulators, topical or oral antibiotics, topical or oral&#xD;
               antihistamines, oral corticosteroids or antineoplastics.&#xD;
  &#xD;
            -  Subjects whose condition does not make them eligible for the study, according to the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CAP Alhambra of Hospitalet de Llobregat</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CAP La Mina Carrer Mar Sant Adrià de Besos</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>atopic skin;</keyword>
    <keyword>eczema;</keyword>
    <keyword>child population;</keyword>
    <keyword>probiotic</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989295
  org study id: WK2023002
  nct id: NCT05989295
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess the efficacy and safety of the use of probiotics as food supplements in reducing
        the SCORAD index in children with atopic skin compared with placebo. This is a randomized,
        placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32
        patients who attend some of the research centers. Patients will be randomized into one of the
        2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05)
        and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12
        weeks, the days of use of topical corticosteroids and one valuations of the skin condition
        (hydration).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  measure: the outbreaks of atopic skin
  time frame: 12 weeks
  description: use the SCORAD index to measure the outbreaks of atopic skin
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: 2.0 g maltodextrin /sachet； Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.
  arm group label: Probiotic group
  arm group type: Active Comparator
  description: (2B CFU/sachet) Lactobacillus rhamnosus LRa05 and maltodextrin Take one sachet a day before meals. Dilute in water； Store in a cool, dry place without sun exposure.
  intervention type: Dietary Supplement
  intervention name: probiotic LRa05
  description: treatment about 12 weeks
  arm group label: Placebo group
  arm group label: Probiotic group
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No