<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/NCT02236429</url>
  </required_header>
  <id_info>
    <org_study_id>VFT-HMO-CTIL</org_study_id>
    <nct_id>NCT02236429</nct_id>
  </id_info>
  <brief_title>Vaginal Flora for Treatment of Bacterial Vaginosis</brief_title>
  <acronym>VFT</acronym>
  <official_title>Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a&#xD;
      vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is&#xD;
      a high rate of recurrence. Almost half of women successfully treated suffer a recurrence&#xD;
      within three months. Complications include risk factors for premature birth, increased&#xD;
      transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The&#xD;
      investigators proposed study is a cost effective treatment based on returning the normal&#xD;
      microbial balance to the vagina. The investigators propose to transfer normal vaginal flora&#xD;
      from healthy individuals to women with BV and thus restore normal vaginal flora and cure this&#xD;
      disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>relief of bacterial vaginosis</measure>
    <time_frame>12 month</time_frame>
    <description>Clinical cure, i.e., absence of vaginal discharge and malodor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laboratory parameters</measure>
    <time_frame>12 months</time_frame>
    <description>absence of all Amsel criteria and Nugent score&lt;3.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Recurrent Bacterial Vaginitis</condition>
  <arm_group>
    <arm_group_label>recurrent bacterial vaginitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>vaginal flora transplant</intervention_name>
    <arm_group_label>recurrent bacterial vaginitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  recurrent BV (4 or more incidences in the past year)&#xD;
&#xD;
          -  recurrence of BV in less than 2 months of antibiotic treatment or need for&#xD;
             prophylactic antibiotic&#xD;
&#xD;
          -  3/4 Amsel criteria and Nugent criteria greater or equal to 7&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or planned pregnancy during the study period&#xD;
&#xD;
          -  other known diseases&#xD;
&#xD;
          -  carriers of Hep B and C&#xD;
&#xD;
          -  HIV or syphilis positive&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahinoam Lev-Sagie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Mediocal Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>August 6, 2022</last_update_submitted>
  <last_update_submitted_qc>August 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bacterial vaginitis</keyword>
  <keyword>vaginal flora</keyword>
  <keyword>microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginitis</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/NCT02236429
org study id: VFT-HMO-CTIL
nct id: NCT02236429
lead sponsor: 
has dmc: No
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a
      vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is
      a high rate of recurrence. Almost half of women successfully treated suffer a recurrence
      within three months. Complications include risk factors for premature birth, increased
      transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The
      investigators proposed study is a cost effective treatment based on returning the normal
      microbial balance to the vagina. The investigators propose to transfer normal vaginal flora
      from healthy individuals to women with BV and thus restore normal vaginal flora and cure this
      disorder.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: relief of bacterial vaginosis
time frame: 12 month
description: Clinical cure, i.e., absence of vaginal discharge and malodor
measure: Laboratory parameters
time frame: 12 months
description: absence of all Amsel criteria and Nugent score<3.
arm group label: recurrent bacterial vaginitis
arm group type: Experimental
intervention type: Biological
intervention name: vaginal flora transplant
arm group label: recurrent bacterial vaginitis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ahinoam Lev-Sagie, MD
role: Principal Investigator
affiliation: Hadassah Mediocal Organization
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginitis
sharing ipd: No