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/NCT06014008</url>
    </required_header>
    <id_info>
      <org_study_id>BIO-2310</org_study_id>
      <nct_id>NCT06014008</nct_id>
    </id_info>
    <brief_title>Effect of L. Paracasei Strain Shirota on Constipation in Healthy US Adults</brief_title>
    <official_title>The Effect of Lacticaseibacillus Paracasei Strain Shirota (LcS) in Healthy US Individuals Suffering From Hard or Lumpy Stools: A Randomized Controlled Open Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yakult U.S.A. Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Biofortis, Merieux NutriSciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dieta Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Yakult U.S.A. Inc.</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 investigate the efficacy of daily consumption of a&#xD;
        fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy&#xD;
        stools in generally healthy U.S. adult population with intermittent bowel movements producing&#xD;
        hard or lumpy stools.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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 (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
      <description>Compare the odds ratio of subjects with hard or lumpy stools (BSFS score of 1 or 2) in at least 25% of the weekly bowel movements between experimental group and control group during the test product consumption period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects that produce hard or lumpy stools (Objectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in stool fuzziness.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in stool fragmentation.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in stool volume.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in stool frequency.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in Patient Assessment of Constipation Quality of Life Questionnaire score (higher scores indicate worse QOL).</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in the proportion of bowel movements having straining during evacuation.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Difference between groups in the Bristol stool form score of the first stool after waking up.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Difference between groups in the fuzziness of the first stool after waking up.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Difference between groups in the fragmentation of the first stool after waking up.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Difference between groups in the consistency of the first stool after waking up.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Difference between groups in the volume of the first stool after waking up.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Clustering analysis on the multivariate data and to identify distinct groups of subjects who receive benefit from the product.</measure>
      <time_frame>Four-week period from the start to the end of test product consumption.</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Constipation</condition>
    <arm_group>
      <arm_group_label>No Intervention group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Not taking test product</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test product consumption group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Test product consumption group</intervention_name>
      <description>Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.</description>
      <arm_group_label>Test product consumption group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥18 and &lt;65 years old at Visit 1.&#xD;
  &#xD;
            2. BMI between ≥18.5 to &lt;30.0 kg/m2.&#xD;
  &#xD;
            3. Has at least 3 bowel movements per week&#xD;
  &#xD;
            4. ≥25% of bowel movements during the 2-week screening period produce hard or lumpy&#xD;
               stools, defined as a Bristol Stool Form Scale (BSFS) score of 1 or 2.&#xD;
  &#xD;
            5. Regular breakfast consumer by self-report.&#xD;
  &#xD;
            6. Has a smartphone supporting either iOS version 11.0 (or later) or Android version 5.0&#xD;
               (or later) operating software capable of downloading and running the Dieta Health app&#xD;
               to collect study data.&#xD;
  &#xD;
            7. Willing to consume the study product per the protocol instructions throughout the&#xD;
               28-day study intervention period.&#xD;
  &#xD;
            8. Willing to maintain habitual dietary, lifestyle, and physical activity (with&#xD;
               exceptions per study instructions) throughout the trial.&#xD;
  &#xD;
            9. Willing to refrain from exclusionary medications, supplements, and products throughout&#xD;
               the study.&#xD;
  &#xD;
           10. Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard&#xD;
               drinks/week throughout the trial.&#xD;
  &#xD;
           11. Non-user of tobacco or nicotine products or former user of any tobacco or nicotine&#xD;
               product (not used within 6 months) and has no plans to change during the study period.&#xD;
               Tobacco products include tobacco, smoking products (including, but not limited to&#xD;
               cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g.,&#xD;
               nicotine gum and/or nicotine patches) within 6 months of Visit 1 (Day 0) and during&#xD;
               the study period.&#xD;
  &#xD;
           12. Non-user or former user of any marijuana or hemp products (not used within 6 months)&#xD;
               of Visit 1 (Day 0) and during the study period and has no plans to use marijuana or&#xD;
               hemp products during the study period. No washout is required for topical marijuana or&#xD;
               hemp products, but subjects are required to abstain from these products during the&#xD;
               study period.&#xD;
  &#xD;
           13. No health conditions that would prevent him/her from fulfilling the study requirements&#xD;
               as judged by the Clinical Investigator on the basis of medical history and screening&#xD;
               physical exam.&#xD;
  &#xD;
           14. Understands the study procedures and signs forms providing informed consent to&#xD;
               participate in the study and authorizes the release of relevant protected health&#xD;
               information to the Clinical Investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any known food allergies or intolerances to dairy or to any of the study product&#xD;
               ingredients.&#xD;
  &#xD;
            2. Consumption of probiotics or fermented products within 14 days of Visit 1 (Day 0) and&#xD;
               during the study.&#xD;
  &#xD;
            3. Presence of a clinically important GI condition that would potentially interfere with&#xD;
               the evaluation of the study product (e.g., inflammatory bowel disease (IBD), irritable&#xD;
               bowel syndrome (IBS), gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac&#xD;
               disease, history of surgery for weight loss, gastroparesis, and clinically significant&#xD;
               lactose or gluten intolerance or other food or ingredient allergies). IBS will be&#xD;
               determined as recurrent abdominal pain or discomfort at least 3 days/month in the last&#xD;
               3 months associated with: (a) improvement with defecation, (b) onset associated with&#xD;
               change in frequency of stool, and (c) onset associated with a change in form&#xD;
               (appearance of stool).&#xD;
  &#xD;
            4. Constipation symptoms caused by primary organic disease of the colon or pelvic floor&#xD;
               or, in the Investigator's opinion, caused by medication (e.g., morphine, codeine).&#xD;
  &#xD;
            5. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma),&#xD;
               hepatic, renal (except history of kidney stones in participants who are symptom free&#xD;
               for 6 months), cardiac (including, but not limited to, atherosclerotic disease,&#xD;
               history of myocardial infarction, peripheral arterial disease, stroke), endocrine&#xD;
               (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic&#xD;
               (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or&#xD;
               anxiety disorders) or biliary condition(s). Conditions which are well-controlled or&#xD;
               resolved will be assessed by the Clinical Investigator on a case-by-case basis.&#xD;
  &#xD;
            6. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood&#xD;
               pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day 0).&#xD;
               Stable use of hypertension medication is allowed [defined as no change in medication&#xD;
               regimen within 90 days of Visit 1 (Day 0)].&#xD;
  &#xD;
            7. Weight loss or gain &gt; 4.5 kg within 90 days of Visit 1 (Day 0), or currently or&#xD;
               planning to be on a weight loss regimen or muscle-building/strengthening program&#xD;
               during the study.&#xD;
  &#xD;
            8. Signs or symptoms of an active infection of clinical relevance within 5 days of Visit&#xD;
               1 (Day 0). The visit may be rescheduled such that all signs and symptoms have resolved&#xD;
               (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day&#xD;
               0).&#xD;
  &#xD;
            9. Major trauma or any other surgical event within 90 days of Visit 1 (Day 0).&#xD;
  &#xD;
           10. History or presence of cancer in the prior 2 years, except for non-melanoma skin&#xD;
               cancer.&#xD;
  &#xD;
           11. Use of proton pump inhibitors, H2 receptor antagonists, corticosteroids, antibiotics,&#xD;
               antifungals, antiparasitics, antidiarrheals, and/or laxatives within 30 days of Visit&#xD;
               1 (Day 0).&#xD;
  &#xD;
           12. Regular (&gt;3 days/week) use of NSAIDs within 14 days of Visit 1 (Day 0).&#xD;
  &#xD;
           13. Exposure to any non-registered drug product within 30 days prior to Visit 1 (Day 0).&#xD;
  &#xD;
           14. Subject is a female who is pregnant, planning to be pregnant during the study period,&#xD;
               lactating, or is of childbearing potential and is unwilling to commit to the use of a&#xD;
               medically approved form of contraception during the study period. The method of&#xD;
               contraception must be recorded.&#xD;
  &#xD;
           15. Recent history (within 12 months of screening; Visit 1; Day 0) of alcohol or substance&#xD;
               abuse. Alcohol abuse is defined as &gt;14 drinks/week (1 drink = 12 oz beer, 5 oz wine,&#xD;
               or 1½ oz distilled spirits).&#xD;
  &#xD;
           16. Recent (within 2 months) participation in any other clinical study prior to Visit 1&#xD;
               (Day 0).&#xD;
  &#xD;
           17. Has a condition the Clinical Investigator believes would interfere with his/her&#xD;
               ability to provide informed consent, comply with the study protocol, which might&#xD;
               confound the interpretation of the study results, or put the subject at undue risk.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dawn Beckman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Biofortis, Merieux NutriSciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hideyuki Shibata, Ph.D.</last_name>
      <phone>714-434-6500</phone>
      <phone_ext>215</phone_ext>
      <email>hideyuki.shibata@yakultusa.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>probiotics</keyword>
    <keyword>Lacticaseibacillus paracasei strain Shirota</keyword>
    <keyword>Bristol stool form scale</keyword>
    <keyword>imaging</keyword>
    <keyword>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/NCT06014008
  org study id: BIO-2310
  nct id: NCT06014008
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to investigate the efficacy of daily consumption of a
        fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy
        stools in generally healthy U.S. adult population with intermittent bowel movements producing
        hard or lumpy stools.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of subjects that produce hard or lumpy stools (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
  time frame: Four-week period from the start to the end of test product consumption.
  description: Compare the odds ratio of subjects with hard or lumpy stools (BSFS score of 1 or 2) in at least 25% of the weekly bowel movements between experimental group and control group during the test product consumption period.
  measure: Proportion of subjects that produce hard or lumpy stools (Objectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in stool fuzziness.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in stool fragmentation.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in stool volume.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in stool frequency.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in Patient Assessment of Constipation Quality of Life Questionnaire score (higher scores indicate worse QOL).
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the proportion of bowel movements having straining during evacuation.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the Bristol stool form score of the first stool after waking up.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the fuzziness of the first stool after waking up.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the fragmentation of the first stool after waking up.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the consistency of the first stool after waking up.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Difference between groups in the volume of the first stool after waking up.
  time frame: Four-week period from the start to the end of test product consumption.
  measure: Clustering analysis on the multivariate data and to identify distinct groups of subjects who receive benefit from the product.
  time frame: Four-week period from the start to the end of test product consumption.
  arm group label: No Intervention group
  arm group type: No Intervention
  description: Not taking test product
  arm group label: Test product consumption group
  arm group type: Experimental
  description: Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.
  intervention type: Other
  intervention name: Test product consumption group
  description: Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.
  arm group label: Test product consumption group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dawn Beckman, MD
  role: Principal Investigator
  affiliation: Biofortis, Merieux NutriSciences
  last name: Hideyuki Shibata, Ph.D.
  phone: 714-434-6500
  phone ext: 215
  email: hideyuki.shibata@yakultusa.com
  responsible party type: Sponsor
  mesh term: Constipation