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/NCT05982743</url>
    </required_header>
    <id_info>
      <org_study_id>YAK-VN-001</org_study_id>
      <nct_id>NCT05982743</nct_id>
    </id_info>
    <brief_title>Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam</brief_title>
    <official_title>A Pilot Study of Using Fermented Milk Containing Lactobacillus Casei Strain Shirota (LcS) in Some Constipated Adults Having High Prevalence of Hard Stools in Vietnam</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yakult Honsha Co., LTD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bach Mai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vietnam National University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Yakult Honsha Co., LTD</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to provide evidence supporting the efficacy of fermented milk&#xD;
        containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A&#xD;
        randomized, controlled trial has been designed on constipated adults with a high prevalence&#xD;
        of hard stools in Vietnam.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 11, 2022</start_date>
    <completion_date type="Actual">March 8, 2023</completion_date>
    <primary_completion_date type="Actual">March 8, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
      <description>Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include &quot;Groups (Yakult/non-treatment)&quot;, &quot;Weeks (first/second two weeks of the intervention period)&quot;, &quot;baseline (median BS score during baseline)&quot; and &quot;Gender (women/men)&quot; as the independent variables. &quot;Groups x Weeks&quot; interaction will not be included because it was absent in the past RCT studies giving Yakult.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with hard or lumpy one (BS score of 1 or 2)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with ideal stool (BS score of 4)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency, as measured by a daily stool diary</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chinese Constipation Questionnaire score</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stool microbiota (increase in the abundance of bifidobacteria)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>BS score of the first stool after waking up (descriptive analysis)</measure>
      <time_frame>During four weeks from the date of the site visit to submit a baseline stool sample.</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">51</enrollment>
    <condition>Constipation</condition>
    <arm_group>
      <arm_group_label>Fermented milk drink</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>No drink</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Lactobacillus casei strain Shirota fermented milk</intervention_name>
      <description>Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period.</description>
      <arm_group_label>Fermented milk drink</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female or male, aged between 18 to 60 years.&#xD;
  &#xD;
            -  Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently.&#xD;
  &#xD;
            -  Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2&#xD;
               weeks of screening period.&#xD;
  &#xD;
            -  Voluntarily provide written informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects whose constipation symptoms are caused by primary organic disease of the&#xD;
               colon or pelvic floora or which, in the Investigator's opinion, is caused by&#xD;
               medication (e.g. morphine, codeine).&#xD;
  &#xD;
            -  Subjects with metabolic disorders, neurological disorders or any significant diseases&#xD;
               or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the&#xD;
               investigator's opinion, would interfere with participation in the study.&#xD;
  &#xD;
            -  Subjects with any known allergic reactions to any ingredients of milk.&#xD;
  &#xD;
            -  Pregnant or nursing (breast-feeding) women.&#xD;
  &#xD;
            -  Subjects who are unable to refrain from or anticipate the use of any medication&#xD;
               (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and&#xD;
               herbal supplements), except for paracetamol, oral contraceptives, or hormonal&#xD;
               replacement therapy from 2-week before the initiation of screening of subject BS score&#xD;
               to the end of the study.&#xD;
  &#xD;
            -  Subjects who are unable to refrain from or anticipate the use of any probiotics,&#xD;
               prebiotics or yogurts from 2-week before the initiation of screening of subject BS&#xD;
               score to the end of the study.&#xD;
  &#xD;
            -  Participation in another study with Investigational product within 2 months prior to&#xD;
               this study.&#xD;
  &#xD;
            -  Drug or alcohol abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vinh Van Hoang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vietnam National University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bach Mai Hospital</name>
        <address>
          <city>Hanoi</city>
          <zip>100000</zip>
          <country>Vietnam</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Vietnam</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Constipation</mesh_term>
    </condition_browse>
    <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/NCT05982743
  org study id: YAK-VN-001
  nct id: NCT05982743
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to provide evidence supporting the efficacy of fermented milk
        containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A
        randomized, controlled trial has been designed on constipated adults with a high prevalence
        of hard stools in Vietnam.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  description: Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult.
  measure: Stool frequency with hard or lumpy one (BS score of 1 or 2)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency with ideal stool (BS score of 4)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency, as measured by a daily stool diary
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Chinese Constipation Questionnaire score
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: Stool microbiota (increase in the abundance of bifidobacteria)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  measure: BS score of the first stool after waking up (descriptive analysis)
  time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
  arm group label: Fermented milk drink
  arm group type: Experimental
  arm group label: No drink
  arm group type: No Intervention
  intervention type: Dietary Supplement
  intervention name: Lactobacillus casei strain Shirota fermented milk
  description: Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period.
  arm group label: Fermented milk drink
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vinh Van Hoang, PhD
  role: Principal Investigator
  affiliation: Vietnam National University
  facility: 
  country: Vietnam
  responsible party type: Sponsor
  mesh term: Constipation
  sharing ipd: No