<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/NCT01708148</url>
  </required_header>
  <id_info>
    <org_study_id>MUW EK982/2010</org_study_id>
    <nct_id>NCT01708148</nct_id>
  </id_info>
  <brief_title>Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients</brief_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 penile linked neovaginal flora in&#xD;
      male-to-female transsexuals after application of oral probiotics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">March 2012</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 day 7 of oral probiotic application</time_frame>
    <description>Using Nugent scoring system, from each participant first swab from neovagina and rectum will be taken before start of oral probiotic use.(baseline information) Second swab from neovagina and rectum 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 neovaginal microbiologic cultures after oral administration of probiotic</measure>
    <time_frame>Day 7 of oral probiotic application</time_frame>
    <description>From each participant, the swab from neovagina and rectum for microbiologic cultures will be taken on the day following the last administration. Isolation of oral applied probiotic strains.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Nugent Score</measure>
    <time_frame>day 0 day 7 of oral probiotic application</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Reduction or Absence of Lactobacilli in Neovaginal Flora</condition>
  <arm_group>
    <arm_group_label>Lactobacilli</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 Participants with verum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 Participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate</description>
    <arm_group_label>Lactobacilli</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>control group would receive a oral lactose placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants underwent the sex reassignment surgery (SRS) with the technique of the&#xD;
        inverted penile skin flap longer than 1 year.&#xD;
&#xD;
        All transsexual women treated according to the Standards of Care of the World Professional&#xD;
        Association of Transgender Health (WPATH).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical signs of vaginal or urinary tract infection,&#xD;
&#xD;
          -  abnormal neovaginal discharge,&#xD;
&#xD;
          -  neoplasia,&#xD;
&#xD;
          -  bleeding,&#xD;
&#xD;
          -  diarrhoea,&#xD;
&#xD;
          -  constipation,&#xD;
&#xD;
          -  rectal pathologies including hemorrhoids,&#xD;
&#xD;
          -  antibiotic therapy in the previous 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gyecology, AKH</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</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>Ass. Prof MD</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/NCT01708148
org study id: MUW EK982/2010
nct id: NCT01708148
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is the improvement of the penile linked neovaginal flora in
      male-to-female transsexuals after application of oral probiotics.
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 day 7 of oral probiotic application
description: Using Nugent scoring system, from each participant first swab from neovagina and rectum will be taken before start of oral probiotic use.(baseline information) Second swab from neovagina and rectum will be taken on the day following the last administration.(information about change in Nugent)
measure: Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic
time frame: Day 7 of oral probiotic application
description: From each participant, the swab from neovagina and rectum for microbiologic cultures will be taken on the day following the last administration. Isolation of oral applied probiotic strains.
measure: Nugent Score
time frame: day 0 day 7 of oral probiotic application
arm group label: Lactobacilli
arm group type: Active Comparator
description: 30 Participants with verum
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 Participants
intervention type: Dietary Supplement
intervention name: Probiotics
description: lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
arm group label: Lactobacilli
intervention type: Other
intervention name: Placebo
description: control group would receive a oral lactose placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Associate Prof. Ljubomir Petricevic MD
investigator title: Ass. Prof MD