<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/NCT02207140</url>
  </required_header>
  <id_info>
    <org_study_id>DKID H-1-2014-051</org_study_id>
    <secondary_id>H-1-2014-051</secondary_id>
    <nct_id>NCT02207140</nct_id>
  </id_info>
  <brief_title>Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly</brief_title>
  <official_title>Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gabriella C. van Zanten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks.&#xD;
      Following randomization, healthy elderly are randomized into two groups receiving probiotics&#xD;
      or placebo. Fecal samples are collected before and after the study. The samples are&#xD;
      investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as&#xD;
      well changes in the fecal metabolome. The effects of the produced metabolites on&#xD;
      mitochondrial activity will moreover be investigated using selected intestinal cell lines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fecal Clostridium difficile numbers</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>fecal microbial composition</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>fecal metabolome</measure>
    <time_frame>24 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Elderly</condition>
  <condition>Probiotics</condition>
  <condition>Clostridium Difficile</condition>
  <condition>Gut Microbiota</condition>
  <condition>Fecal Metabolome</condition>
  <arm_group>
    <arm_group_label>probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HOWARU Restore</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>microcrystalline cellulose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>HOWARU Restore</intervention_name>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_label>probiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  aged 75 years or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with chronic bowel diseases&#xD;
&#xD;
          -  Individuals with severe immunosuppression&#xD;
&#xD;
          -  Individuals with dementia&#xD;
&#xD;
          -  Individuals who are terminally ill&#xD;
&#xD;
          -  If severe/prolonged illness occurs after the start of the test, the subject must drop&#xD;
             out of the study&#xD;
&#xD;
          -  Individuals who have consumed probiotic products after two weeks prior to the start of&#xD;
             the study or during it.&#xD;
&#xD;
          -  Subjects with a history of substance abuse&#xD;
&#xD;
          -  Subjects that, in the investigators opinion, are not expected to complete the study&#xD;
             succesfully&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriella C van Zanten, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen, Dept. of Food Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen</name>
      <address>
        <city>Frederiksberg C</city>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>June 20, 2016</last_update_submitted>
  <last_update_submitted_qc>June 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Gabriella C. van Zanten</investigator_full_name>
    <investigator_title>Postdoc</investigator_title>
  </responsible_party>
  <!-- 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/NCT02207140
org study id: DKID H-1-2014-051
secondary id: H-1-2014-051
nct id: NCT02207140
lead sponsor: 
has dmc: No
The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks.
      Following randomization, healthy elderly are randomized into two groups receiving probiotics
      or placebo. Fecal samples are collected before and after the study. The samples are
      investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as
      well changes in the fecal metabolome. The effects of the produced metabolites on
      mitochondrial activity will moreover be investigated using selected intestinal cell lines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fecal Clostridium difficile numbers
time frame: 24 weeks
measure: fecal microbial composition
time frame: 24 weeks
measure: fecal metabolome
time frame: 24 weeks
arm group label: probiotic
arm group type: Experimental
description: HOWARU Restore
arm group label: placebo
arm group type: Placebo Comparator
description: microcrystalline cellulose
intervention type: Dietary Supplement
intervention name: HOWARU Restore
arm group label: placebo
arm group label: probiotic
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriella C van Zanten, PhD
role: Principal Investigator
affiliation: University of Copenhagen, Dept. of Food Science
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Gabriella C. van Zanten
investigator title: Postdoc