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Probiotic Implementation as Help in Solving Vaginal Infections

Primary Purpose

Vaginal Infection, ASC-US

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus rhamnosus BMX 54
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaginal Infection focused on measuring probiotics implementation, HPV infection, vaginosis, yeast vaginitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age>18 years
  • documented BV or yeast vaginitis associated with HPV-infection documented as PAP-smear abnormalities (ASCUS, L-SIL or H-SIL histologically demonstrated as CIN1) and/or positive for HPV-DNA

Exclusion Criteria:

  • pregnancy or breastfeeding
  • previous abnormal PAP-smear
  • CIN2-3
  • concomitant malignancies
  • immunological diseases
  • severe comorbidities
  • prolonged corticosteroid treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Group 1

    Group 2

    Arm Description

    Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation

    Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration

    Outcomes

    Primary Outcome Measures

    Evaluation of a possible role of probiotics in vaginal infections resolution
    Changes in clinical responses (absence of typical symptoms associated with vaginal infections)

    Secondary Outcome Measures

    Treatment-related adverse events record
    Assessed by CTCAE v4.0

    Full Information

    First Posted
    November 14, 2017
    Last Updated
    December 8, 2017
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03372395
    Brief Title
    Probiotic Implementation as Help in Solving Vaginal Infections
    Official Title
    Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being. The aim of the study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPVinfections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.
    Detailed Description
    A total of 117 women affected by bacterial vaginosis or vaginitis with concomitant HPV infections were enrolled at Department of Gynecological Obstetrics and Urological Sciences, La Sapienza University, Rome, Italy between February 2015 and March 2016. Women were randomized in two groups, standard treatment (metronidazole 500 mg twice a day for 7 days or fluconazole 150 mg orally once a day for 2 consecutive days) plus short-term (3 months) vaginal Lactobacillus implementation (group 1, short probiotics treatment protocol group, n=60) versus the same standard treatment plus long-lasting (6 months) vaginal Lactobacillus rhamnosus BMX 54 administration (group 2, treatment group, n=57).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Infection, ASC-US
    Keywords
    probiotics implementation, HPV infection, vaginosis, yeast vaginitis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Sequential Assignment
    Model Description
    Pilot study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    117 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Other
    Arm Description
    Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
    Intervention Type
    Other
    Intervention Name(s)
    Lactobacillus rhamnosus BMX 54
    Intervention Description
    Given once a day for 10 days, once every 3 days for 20 days and then once every 5 days for other 2 months in all patients (probiotics implementation for 3 months comprehensively).
    Primary Outcome Measure Information:
    Title
    Evaluation of a possible role of probiotics in vaginal infections resolution
    Description
    Changes in clinical responses (absence of typical symptoms associated with vaginal infections)
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Treatment-related adverse events record
    Description
    Assessed by CTCAE v4.0
    Time Frame
    9 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age>18 years documented BV or yeast vaginitis associated with HPV-infection documented as PAP-smear abnormalities (ASCUS, L-SIL or H-SIL histologically demonstrated as CIN1) and/or positive for HPV-DNA Exclusion Criteria: pregnancy or breastfeeding previous abnormal PAP-smear CIN2-3 concomitant malignancies immunological diseases severe comorbidities prolonged corticosteroid treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26142892
    Citation
    Recine N, Palma E, Domenici L, Giorgini M, Imperiale L, Sassu C, Musella A, Marchetti C, Muzii L, Benedetti Panici P. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet. 2016 Jan;293(1):101-107. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5.
    Results Reference
    background
    PubMed Identifier
    29304768
    Citation
    Palma E, Recine N, Domenici L, Giorgini M, Pierangeli A, Panici PB. Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection. BMC Infect Dis. 2018 Jan 5;18(1):13. doi: 10.1186/s12879-017-2938-z.
    Results Reference
    derived

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