<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/NCT04433208</url>
  </required_header>
  <id_info>
    <org_study_id>20-CT-001</org_study_id>
    <nct_id>NCT04433208</nct_id>
  </id_info>
  <brief_title>Dietary Supplement With and Without a Probiotic</brief_title>
  <official_title>Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prolacta Bioscience</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prolacta Bioscience</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>
      Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain&#xD;
      organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance&#xD;
      gastrointestinal colonization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the synergy of the use of a complex oligosaccharide with and without&#xD;
      a probiotic on the human microbiome in healthy volunteers. The combination should support&#xD;
      general gastrointestinal health.&#xD;
&#xD;
      The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60&#xD;
      healthy adult volunteers ages 18-75.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the changes in microbiome species abundance and diversity from baseline until end of study</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of blood parameters, such as cytokine levels</measure>
    <time_frame>30 days</time_frame>
    <description>Blood samples will be collected for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants requiring PPI for probiotic engraftment</measure>
    <time_frame>30 days</time_frame>
    <description>Determination of the need for protection of the probiotic from stomach acid in order for engraftment of the organism into the gut microbiome to occur</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and severity (mild, moderate, or severe) of adverse events and relationship to the study product.</measure>
    <time_frame>30 days</time_frame>
    <description>Adverse events will be summarized by severity and relationship to the study drug</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Healthy Adult Subjects</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (PPI + probiotic)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Cohort 1 will take a PPI and a probiotic orally once daily on Days 1-7. Subjects will mix the probiotic in an aqueous diluent supplied by the pharmacy and ingest between 1-2 hours after taking a PPI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Complex oligosaccharide + PPI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Cohort 2 will take the complex oligosaccharide orally twice daily on Days 1-14. On Days 1-7, the first dose of the complex oligosaccharide will be taken between 1-2 hours after taking a PPI. On Days 8-14, subjects will not take a PPI prior to the complex oligosaccharide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Cohort 3, 4, and 6 will take a complex oligosaccharide orally twice daily (doses will vary per cohort) on Days 1-14 in combination with a probiotic orally once daily on Days 1-7. Cohort 5 will undergo the same dosing regimen a second time on days 29-43</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Complex oligosaccharide</intervention_name>
    <description>Complex oligosaccharide concentrate</description>
    <arm_group_label>Cohort 2 (Complex oligosaccharide + PPI)</arm_group_label>
    <arm_group_label>Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Probiotic</description>
    <arm_group_label>Cohort 1 (PPI + probiotic)</arm_group_label>
    <arm_group_label>Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PPI</intervention_name>
    <description>Over-the-counter proton pump inhibitor (PPI)</description>
    <arm_group_label>Cohort 1 (PPI + probiotic)</arm_group_label>
    <arm_group_label>Cohort 2 (Complex oligosaccharide + PPI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults between the ages of 18-75 years&#xD;
&#xD;
          -  Willingness to complete all study procedures and clinic visits, and provide required&#xD;
             samples&#xD;
&#xD;
          -  Provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding, or intend to become pregnant during the&#xD;
             course of this study&#xD;
&#xD;
          -  Subjects with history of lactose intolerance&#xD;
&#xD;
          -  Subjects who are on a PPI regimen&#xD;
&#xD;
          -  Subjects who have taken a probiotic during the previous 30 days, or intends to take a&#xD;
             probiotic during the study.&#xD;
&#xD;
          -  Subjects who have taken antibiotics within 120 days&#xD;
&#xD;
          -  Alcohol or drug abuse during the last 12 months, including passing a screen for drugs&#xD;
             of abuse at screening&#xD;
&#xD;
          -  Unstable medical condition, in the opinion of the investigator&#xD;
&#xD;
          -  Clinically significant abnormal laboratory test results at screening&#xD;
&#xD;
          -  Participation in a clinical research trial within 30 days prior to screening&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Any condition which may preclude subject's ability to comply with and complete the&#xD;
             study or may pose a risk to the health of the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>WCCT Global</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04433208
org study id: 20-CT-001
nct id: NCT04433208
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain
      organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance
      gastrointestinal colonization.
The study will evaluate the synergy of the use of a complex oligosaccharide with and without
      a probiotic on the human microbiome in healthy volunteers. The combination should support
      general gastrointestinal health.

      The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60
      healthy adult volunteers ages 18-75.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Evaluation of the changes in microbiome species abundance and diversity from baseline until end of study
time frame: 30 days
measure: Concentration of blood parameters, such as cytokine levels
time frame: 30 days
description: Blood samples will be collected for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
measure: Percentage of participants requiring PPI for probiotic engraftment
time frame: 30 days
description: Determination of the need for protection of the probiotic from stomach acid in order for engraftment of the organism into the gut microbiome to occur
measure: Number and severity (mild, moderate, or severe) of adverse events and relationship to the study product.
time frame: 30 days
description: Adverse events will be summarized by severity and relationship to the study drug
arm group label: Cohort 1 (PPI + probiotic)
arm group type: Experimental
description: Subjects in Cohort 1 will take a PPI and a probiotic orally once daily on Days 1-7. Subjects will mix the probiotic in an aqueous diluent supplied by the pharmacy and ingest between 1-2 hours after taking a PPI.
arm group label: Cohort 2 (Complex oligosaccharide + PPI)
arm group type: Experimental
description: Subjects in Cohort 2 will take the complex oligosaccharide orally twice daily on Days 1-14. On Days 1-7, the first dose of the complex oligosaccharide will be taken between 1-2 hours after taking a PPI. On Days 8-14, subjects will not take a PPI prior to the complex oligosaccharide.
arm group label: Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)
arm group type: Experimental
description: Subjects in Cohort 3, 4, and 6 will take a complex oligosaccharide orally twice daily (doses will vary per cohort) on Days 1-14 in combination with a probiotic orally once daily on Days 1-7. Cohort 5 will undergo the same dosing regimen a second time on days 29-43
intervention type: Dietary Supplement
intervention name: Complex oligosaccharide
description: Complex oligosaccharide concentrate
arm group label: Cohort 2 (Complex oligosaccharide + PPI)
arm group label: Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)
intervention type: Dietary Supplement
intervention name: Probiotic
description: Probiotic
arm group label: Cohort 1 (PPI + probiotic)
arm group label: Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)
intervention type: Other
intervention name: PPI
description: Over-the-counter proton pump inhibitor (PPI)
arm group label: Cohort 1 (PPI + probiotic)
arm group label: Cohort 2 (Complex oligosaccharide + PPI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: May 8, 2023