<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/NCT01667653</url>
  </required_header>
  <id_info>
    <org_study_id>11PDHD</org_study_id>
    <nct_id>NCT01667653</nct_id>
  </id_info>
  <brief_title>Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment</brief_title>
  <official_title>A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danisco</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is randomized, double-blind, placebo controlled, single centre; 21 days phase II&#xD;
      clinical trial on healthy volunteers. Following baseline visit at the day of randomization,&#xD;
      treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic&#xD;
      treatment subjects will also receive the study treatment, either probiotic or placebo. Daily&#xD;
      Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect&#xD;
      fecal samples for microbiological examination. The primary objective of the study is to&#xD;
      evaluate the maintenance of intestinal microbiota composition during antibiotic treatment&#xD;
      with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects&#xD;
      associated with antibiotic use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg</measure>
    <time_frame>3 weeks</time_frame>
    <description>Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The influence of probiotics on side effects associated with antibiotic use</measure>
    <time_frame>3-weeks</time_frame>
    <description>Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Antibiotic Therapy</condition>
  <arm_group>
    <arm_group_label>Augmentin/Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are provided in double blinded fashion probiotic to take with antibiotics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmentin/placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are provided in double blinded fashion placebo to take with antibiotics</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Probiotic capsule once daily</description>
    <arm_group_label>Augmentin/Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule once daily</description>
    <arm_group_label>Augmentin/placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18 to 50 years.&#xD;
&#xD;
          -  Healthy as determined by laboratory results, medical history and physical exam&#xD;
&#xD;
          -  Willing to give voluntary, written, informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             course of the trial&#xD;
&#xD;
          -  Body mass index ≥ 30 kg/m2&#xD;
&#xD;
          -  Average number of formed bowel movements &gt; 3 per day or &lt; 3 per week&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Participation in a clinical research trial within 30 days prior to randomization&#xD;
&#xD;
          -  Use of antibiotics within 60 days prior to randomization.&#xD;
&#xD;
          -  Habitual use of pro- and/or prebiotic products.&#xD;
&#xD;
          -  Follows a vegetarian or vegan diet&#xD;
&#xD;
          -  Unstable medical conditions&#xD;
&#xD;
          -  Any evidence of acute or chronic gastrointestinal disorder&#xD;
&#xD;
          -  Alcohol use &gt; 2 standard alcoholic drinks per day and/or alcohol or drug abuse within&#xD;
             past year&#xD;
&#xD;
          -  Allergy or sensitivity to test product ingredients or antibiotic&#xD;
&#xD;
          -  Any other condition which in the Investigator's opinion may adversely affect the&#xD;
             subject's ability to complete the study or its measures or which may pose significant&#xD;
             risk to the subject&#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>
  <location>
    <facility>
      <name>KGK Synergize Inc.</name>
      <address>
        <city>London/Ontario</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>March 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01667653
org study id: 11PDHD
nct id: NCT01667653
lead sponsor: 
collaborator: 
has dmc: No
This is randomized, double-blind, placebo controlled, single centre; 21 days phase II
      clinical trial on healthy volunteers. Following baseline visit at the day of randomization,
      treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic
      treatment subjects will also receive the study treatment, either probiotic or placebo. Daily
      Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect
      fecal samples for microbiological examination. The primary objective of the study is to
      evaluate the maintenance of intestinal microbiota composition during antibiotic treatment
      with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects
      associated with antibiotic use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg
time frame: 3 weeks
description: Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR.
measure: The influence of probiotics on side effects associated with antibiotic use
time frame: 3-weeks
description: Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,
arm group label: Augmentin/Probiotic
arm group type: Experimental
description: Participants are provided in double blinded fashion probiotic to take with antibiotics
arm group label: Augmentin/placebo
arm group type: Experimental
description: Participants are provided in double blinded fashion placebo to take with antibiotics
intervention type: Dietary Supplement
intervention name: Probiotic
description: Probiotic capsule once daily
arm group label: Augmentin/Probiotic
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo capsule once daily
arm group label: Augmentin/placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor