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Probiotic Implementation as Help in Solving Vaginal Infections

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ClinicalTrials.gov Identifier: NCT03372395
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Pierluigi Benedetti Panici, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Vaginal Infection ASC-US Other: Lactobacillus rhamnosus BMX 54 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
Actual Study Start Date : February 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Group 1
Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
Other: Lactobacillus rhamnosus BMX 54
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).

Experimental: Group 2
Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
Other: Lactobacillus rhamnosus BMX 54
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 Measures :
  1. Evaluation of a possible role of probiotics in vaginal infections resolution [ Time Frame: 9 months ]
    Changes in clinical responses (absence of typical symptoms associated with vaginal infections)


Secondary Outcome Measures :
  1. Treatment-related adverse events record [ Time Frame: 9 months ]
    Assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pierluigi Benedetti Panici, Full Professor and Director of Dept Obstetrics and Gynecology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03372395    
Other Study ID Numbers: 3642
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierluigi Benedetti Panici, University of Roma La Sapienza:
probiotics implementation
HPV infection
vaginosis
yeast vaginitis
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes