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Probiotic Implementation as Help in Solving Vaginal Infections

NCT ID: NCT03372395

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

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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

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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).

Conditions

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Vaginal Infection ASC-US

Keywords

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probiotics implementation HPV infection vaginosis yeast vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Pilot study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type OTHER

Lactobacillus rhamnosus BMX 54

Intervention Type OTHER

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).

Group 2

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

Group Type EXPERIMENTAL

Lactobacillus rhamnosus BMX 54

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Pierluigi Benedetti Panici

Full Professor and Director of Dept Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 26142892 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29304768 (View on PubMed)

Other Identifiers

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3642

Identifier Type: -

Identifier Source: org_study_id