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/NCT06001190</url>
    </required_header>
    <id_info>
      <org_study_id>CORPG6M0171</org_study_id>
      <nct_id>NCT06001190</nct_id>
    </id_info>
    <brief_title>The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women</brief_title>
    <official_title>The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung Memorial Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A single-blind, randomized, and probiotic-treatment including adult women with vaginitis&#xD;
        and/or HPV positive. After oral probiotics, all participants will be followd-up cervical&#xD;
        swabs and vaginal microbiome alteration till the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>improvement alteration of vaginal microbiome</measure>
      <time_frame>3 months</time_frame>
      <description>16s rRNA</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome</condition>
    <arm_group>
      <arm_group_label>probiotic intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>probiotic group with daily treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>placebo-controlled with daily treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>probiotic:Lactobacillus crispatus</intervention_name>
      <description>We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.</description>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_label>probiotic intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed as vaginal viginitis&#xD;
  &#xD;
            -  willing to sign permit&#xD;
  &#xD;
            -  willing to regular follow up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Virgin&#xD;
  &#xD;
            -  Severe cervix pathology CINII or CIN III&#xD;
  &#xD;
            -  Confirmed cervical cancer&#xD;
  &#xD;
            -  under long term antibiotics due to other physical condition&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kaohsiung Chang Gung Memorial Hospital</name>
        <address>
          <city>Kaohsiung</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu-Che Ou, MD</last_name>
        <phone>+886-7-732-7123</phone>
        <phone_ext>8916</phone_ext>
        <email>tedycou@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Papillomavirus Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06001190
  org study id: CORPG6M0171
  nct id: NCT06001190
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A single-blind, randomized, and probiotic-treatment including adult women with vaginitis
        and/or HPV positive. After oral probiotics, all participants will be followd-up cervical
        swabs and vaginal microbiome alteration till the end of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: improvement alteration of vaginal microbiome
  time frame: 3 months
  description: 16s rRNA
  arm group label: probiotic intervention
  arm group type: Active Comparator
  description: probiotic group with daily treatment
  arm group label: placebo
  arm group type: Placebo Comparator
  description: placebo-controlled with daily treatment
  intervention type: Dietary Supplement
  intervention name: probiotic:Lactobacillus crispatus
  description: We seek to observe that probiotic supplement(arm A) can improve vagina microbiome distribution by comapred to placebo group(arm B) in our study.
  arm group label: placebo
  arm group label: probiotic intervention
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Papillomavirus Infections
  sharing ipd: Undecided