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/NCT05980988</url>
    </required_header>
    <id_info>
      <org_study_id>WK2023003</org_study_id>
      <nct_id>NCT05980988</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Probiotic in Regulating Chronic Constipation</brief_title>
    <official_title>Efficacy and Safety of Probiotic BLa80 in Modulating Bowel Habits in Subjects With Chronic Constipation</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 evaluate the effectiveness and safety of the use of probiotics as food supplements in&#xD;
        regulating the intestinal habit of subjects with chronic constipation, in comparison with&#xD;
        placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 9, 2021</start_date>
    <completion_date type="Actual">April 6, 2023</completion_date>
    <primary_completion_date type="Actual">February 2, 2023</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>Single (Participant)</masking>
      <masking_description>Double（Participant, Investigator)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>changes in fecal state</measure>
      <time_frame>84 days</time_frame>
      <description>use Bristol Scale to record the type of fecal state</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">46</enrollment>
    <condition>Chronic Constipation</condition>
    <arm_group>
      <arm_group_label>Probiotic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic</intervention_name>
      <description>The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).</description>
      <arm_group_label>Probiotic group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with chronic constipation (duration more than 3 months with less than three bowel&#xD;
          movements per week and/or Bristol Scale 1 and 2).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diabetic patients.&#xD;
  &#xD;
            2. Pregnant patients.&#xD;
  &#xD;
            3. Breastfeeding patients.&#xD;
  &#xD;
            4. Patients requiring antibiotic treatment.&#xD;
  &#xD;
            5. Patients requiring treatment with tricyclic antidepressants, antiepileptics,&#xD;
               antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil,&#xD;
               monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and&#xD;
               calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs.&#xD;
  &#xD;
            6. Patients who change the type of diet during the study.&#xD;
  &#xD;
            7. Patients with allergy or intolerance to any of the ingredients in the formulation of&#xD;
               the product under study.&#xD;
  &#xD;
            8. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or&#xD;
               other factors that limit their ability to cooperate during the study.&#xD;
  &#xD;
            9. Excessive alcohol consumption (&gt;3 glasses of wine or beer/day).&#xD;
  &#xD;
           10. Subjects whose condition does not make them eligible for the study, according to the&#xD;
               researcher.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>METHODEX SL</last_name>
      <role>Study Chair</role>
      <affiliation>Methodex</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CAP Can Bou Castelldefels and CAP Corbera de Llobregat</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Family and Community Medicine CAP Roger</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Probiotics；Chronic constipation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Constipation</mesh_term>
    </condition_browse>
    <!-- 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/NCT05980988
  org study id: WK2023003
  nct id: NCT05980988
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the effectiveness and safety of the use of probiotics as food supplements in
        regulating the intestinal habit of subjects with chronic constipation, in comparison with
        placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Double（Participant, Investigator)
  measure: changes in fecal state
  time frame: 84 days
  description: use Bristol Scale to record the type of fecal state
  arm group label: Probiotic group
  arm group type: Experimental
  description: 2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.
  arm group label: placebo
  arm group type: Placebo Comparator
  description: Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.
  intervention type: Dietary Supplement
  intervention name: Probiotic
  description: The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).
  arm group label: Probiotic group
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Placebo
  arm group label: placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: METHODEX SL
  role: Study Chair
  affiliation: Methodex
  facility: 
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Constipation