Probiotic Implementation as Help in Solving Vaginal Infections

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT03372395

Collaborator

(none)

117

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Pilot studyPilot 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 :

Feb 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).

Arm

Intervention/Treatment

Other: 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).

Outcome Measures

Primary Outcome Measures

Evaluation of a possible role of probiotics in vaginal infections resolution [9 months]
Changes in clinical responses (absence of typical symptoms associated with vaginal infections)

Secondary Outcome Measures

Treatment-related adverse events record [9 months]
Assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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