xml: <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/NCT05963711</url>
    </required_header>
    <id_info>
      <org_study_id>0463-22-HMO</org_study_id>
      <nct_id>NCT05963711</nct_id>
    </id_info>
    <brief_title>The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation</brief_title>
    <official_title>The Penile Microbiome in Partners of Women With Recurrent BV and Its Response to Decolonization Protocol</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        There is strong observational evidence that sexual activity plays a key role in Bacterial&#xD;
        Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of&#xD;
        sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria&#xD;
        (BVAB) between sexual partners.&#xD;
  &#xD;
        Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners&#xD;
        is not recommended, based on prior treatment studies of male partners of women with recurrent&#xD;
        BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly&#xD;
        protective against recurrent BV.&#xD;
  &#xD;
        This study aims to evaluate the male-partner's genital microbiome as a potential source of&#xD;
        BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and&#xD;
        whether disinfection can eliminate BV-associated penile microbiome.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 17, 2022</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Penile microbiome composition</measure>
      <time_frame>1 year</time_frame>
      <description>Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Penile microbiome composition after disinfection</measure>
      <time_frame>1 year</time_frame>
      <description>Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Bacterial Vaginosis</condition>
    <condition>Microbial Colonization</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>chlorhexidine gluconate 4%</intervention_name>
      <description>In case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes.&#xD;
  In case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.</description>
      <other_name>2% clindamycin cream</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject has s female partner who participates in VMT study ( NCT04517487).&#xD;
  &#xD;
            -  The subject is defined by the woman as her male regular partner.&#xD;
  &#xD;
            -  Willing to use a condom as instructed by the protocol.&#xD;
  &#xD;
            -  Willing to comply with decolonization protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A known skin disease involving the penile skin.&#xD;
  &#xD;
            -  A known sensitivity to chlorhexidine gluconate&#xD;
  &#xD;
            -  Any of the partners (female/male) has more than one sexual partner.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hadassah Medical Center</name>
        <address>
          <city>Jerusalem</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahinoam Lev Sagie, MD</last_name>
        <phone>+972-54-4327178</phone>
        <email>levsagie@netvision.net.il</email>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
      <investigator_full_name>Ahinoam Lev-Sagie</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Penile microbiome</keyword>
    <keyword>Vaginal microbiome transplant</keyword>
    <keyword>Male partners</keyword>
    <keyword>Bacterial vaginosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaginosis, Bacterial</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Vaginal Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
      <mesh_term>Chlorhexidine gluconate</mesh_term>
      <mesh_term>Clindamycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963711
  org study id: 0463-22-HMO
  nct id: NCT05963711
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is strong observational evidence that sexual activity plays a key role in Bacterial
        Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of
        sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria
        (BVAB) between sexual partners.
  
        Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners
        is not recommended, based on prior treatment studies of male partners of women with recurrent
        BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly
        protective against recurrent BV.
  
        This study aims to evaluate the male-partner's genital microbiome as a potential source of
        BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and
        whether disinfection can eliminate BV-associated penile microbiome.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Penile microbiome composition
  time frame: 1 year
  description: Characterization of the penile microbial communities using shotgun analysis, and their similarity to the vaginal microbiota composition of their sexual partner.
  measure: Penile microbiome composition after disinfection
  time frame: 1 year
  description: Characterization of the penile microbiome composition using shotgun analysis, after disinfection protocol or antibiotic use.
  intervention type: Other
  intervention name: chlorhexidine gluconate 4%
  description: In case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes.
  In case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.
  other name: 2% clindamycin cream
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Hadassah Medical Organization
  investigator full name: Ahinoam Lev-Sagie
  investigator title: Professor
  mesh term: Vaginosis, Bacterial
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Vaginal Diseases
  mesh term: Chlorhexidine
  mesh term: Chlorhexidine gluconate
  mesh term: Clindamycin
  sharing ipd: No