<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/NCT01716910</url>
  </required_header>
  <id_info>
    <org_study_id>DK-H-4-2010-137</org_study_id>
    <nct_id>NCT01716910</nct_id>
  </id_info>
  <brief_title>Effect of Synbiotic on Composition of Human Gut Microbiota and Production of Short and Branched-chain Fatty Acids</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</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>
      This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week&#xD;
      clinical trial on healthy volunteers. Following a two week run-in-period, subjects were&#xD;
      randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a&#xD;
      3-week wash-out period before the second treatment period, followed by a another wash-out&#xD;
      period. Volunteers completed questionnaires for each period on overall health and well being,&#xD;
      stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to&#xD;
      collect fecal samples for investigation of microbiological and microbial metabolites before&#xD;
      and after three treatment periods. The primary objective of the study is tan increase in&#xD;
      fecal butyrate concentration. Secondary objectives are changes in microbiota composition and&#xD;
      short-chain fatty acids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>increase in fecal butyrate concentration</measure>
    <time_frame>12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in composition of microbiota</measure>
    <time_frame>12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in short-chain fatty acids</measure>
    <time_frame>12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Synbiotics</condition>
  <condition>Healthy Humans</condition>
  <condition>Composition of Gut Microbiota</condition>
  <condition>Short and Branched-chain Fatty Acids</condition>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Synbiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Combination of Lactobacillus acidophilus NCFM and cellobiose</intervention_name>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_label>Synbiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:healthy individuals between 18-50 years of age who had not used&#xD;
        antibiotics three months prior to the trial&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic illness&#xD;
&#xD;
          -  regular intake of medication (except birth-control pills)&#xD;
&#xD;
          -  post-menopausal women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriella C. van Zanten, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gabriella C van Zanten, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark</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>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Gabriella C. van Zanten</investigator_full_name>
    <investigator_title>PhD student</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/NCT01716910
org study id: DK-H-4-2010-137
nct id: NCT01716910
lead sponsor: 
has dmc: No
This is a randomized, double-blind, placebo controlled, cross-over, single centre, 14 week
      clinical trial on healthy volunteers. Following a two week run-in-period, subjects were
      randomized, and treatment with synbiotic or placebo for 21 days was given, followed by a
      3-week wash-out period before the second treatment period, followed by a another wash-out
      period. Volunteers completed questionnaires for each period on overall health and well being,
      stool frequency and consistency and gastrointestinal symptoms. The subjects were asked to
      collect fecal samples for investigation of microbiological and microbial metabolites before
      and after three treatment periods. The primary objective of the study is tan increase in
      fecal butyrate concentration. Secondary objectives are changes in microbiota composition and
      short-chain fatty acids.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: increase in fecal butyrate concentration
time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
measure: changes in composition of microbiota
time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
measure: changes in short-chain fatty acids
time frame: 12 weeks (2x 3 week intervention periods which each were followed by a 3 week wash-out period, sampling at the end of each period)
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: 'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day
arm group label: Synbiotic
arm group type: Active Comparator
description: 'Combination of Lactobacillus acidophilus NCFM and cellobiose', Sachet, 5 g/day + 10e9 CFU
intervention type: Dietary Supplement
intervention name: Combination of Lactobacillus acidophilus NCFM and cellobiose
arm group label: Maltodextrin
arm group label: Synbiotic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriella C. van Zanten, PhD student
role: Principal Investigator
affiliation: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
last name: Gabriella C van Zanten, PhD student
role: Principal Investigator
affiliation: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Gabriella C. van Zanten
investigator title: PhD student