<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/NCT01723592</url>
  </required_header>
  <id_info>
    <org_study_id>MUW EK 1417/2012</org_study_id>
    <nct_id>NCT01723592</nct_id>
  </id_info>
  <brief_title>Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.</brief_title>
  <official_title>The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Natural Resources and Life Sciences, Vienna, Austria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is the improvement of the vaginal flora by at least two grades of the&#xD;
      Nugent scale after application of oral probiotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is the improvement of the vaginal flora by at least two grades of the&#xD;
      Nugent scale. Improvement of Nugent scores should be considered the primary end point of the&#xD;
      study. The outcome of the study would be considered positive if significantly more women in&#xD;
      the verum cohort achieve such improvement than in the placebo cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Nugent score between baseline and end of treatment (improvement or no improvement)</measure>
    <time_frame>day 0, 7 and day 14 of oral probiotic application</time_frame>
    <description>Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic</measure>
    <time_frame>day 0, 7 and day 14 after oral probiotic application</time_frame>
    <description>From each participant, a vaginal swab for microbiologic cultures will be taken on the first day and that following the last administration for Isolation of oral applied probiotic strains as well as non-lactobacilli-flora.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 participants in this group receive a oral lactose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 participants in this group receiving oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains belonging to the species:&#xD;
L.rhamnosus/ LbV96 (DSM 22560)&#xD;
L.jensenii /LbV 116 (DSM 22567)&#xD;
L.crispatus/ Lbv88 (DSM 22566)&#xD;
L.gasseri /LbV 150N (DSM 22583)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583)</description>
    <arm_group_label>Probiotics</arm_group_label>
    <other_name>L.rhamnosus/ LbV96 (DSM 22560)</other_name>
    <other_name>L.jensenii /LbV 116 (DSM 22567)</other_name>
    <other_name>L.crispatus/ Lbv88 (DSM 22566)</other_name>
    <other_name>L.gasseri /LbV 150N (DSM 22583)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral lactose placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks&#xD;
        postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with&#xD;
        Nugent scores between 4 and 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring&#xD;
        antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert Kiss, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Vienna, Dept. of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna - Department of Obstetrics and Gynecology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>June 4, 2017</last_update_submitted>
  <last_update_submitted_qc>June 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Associate Prof. Ljubomir Petricevic MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>chemotherapy</keyword>
  <keyword>vaginal flora</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01723592
org study id: MUW EK 1417/2012
nct id: NCT01723592
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is the improvement of the vaginal flora by at least two grades of the
      Nugent scale after application of oral probiotics.
The aim of this study is the improvement of the vaginal flora by at least two grades of the
      Nugent scale. Improvement of Nugent scores should be considered the primary end point of the
      study. The outcome of the study would be considered positive if significantly more women in
      the verum cohort achieve such improvement than in the placebo cohort.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: change in Nugent score between baseline and end of treatment (improvement or no improvement)
time frame: day 0, 7 and day 14 of oral probiotic application
description: Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)
measure: Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic
time frame: day 0, 7 and day 14 after oral probiotic application
description: From each participant, a vaginal swab for microbiologic cultures will be taken on the first day and that following the last administration for Isolation of oral applied probiotic strains as well as non-lactobacilli-flora.
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 participants in this group receive a oral lactose placebo
arm group label: Probiotics
arm group type: Active Comparator
description: 30 participants in this group receiving oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains belonging to the species:
L.rhamnosus/ LbV96 (DSM 22560)
L.jensenii /LbV 116 (DSM 22567)
L.crispatus/ Lbv88 (DSM 22566)
L.gasseri /LbV 150N (DSM 22583)
intervention type: Dietary Supplement
intervention name: Probiotics
description: Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583)
arm group label: Probiotics
other name: L.rhamnosus/ LbV96 (DSM 22560)
other name: L.jensenii /LbV 116 (DSM 22567)
other name: L.crispatus/ Lbv88 (DSM 22566)
other name: L.gasseri /LbV 150N (DSM 22583)
intervention type: Dietary Supplement
intervention name: Oral lactose placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Herbert Kiss, MD
role: Study Director
affiliation: Medical University of Vienna, Dept. of Obstetrics and Gynecology
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Associate Prof. Ljubomir Petricevic MD
investigator title: Assistant Professor
mesh term: Breast Neoplasms
sharing ipd: No