Probiotic Implementation as Help in Solving Vaginal Infections

Study Overview
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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).

Official Title
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Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection

Conditions
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Vaginal Infection, ASC-US

Intervention / Treatment
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* Other: Lactobacillus rhamnosus BMX 54


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation | Other: Lactobacillus rhamnosus BMX 54<br>* 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).<br>|
| Experimental: Group 2<br>Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration | Other: Lactobacillus rhamnosus BMX 54<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of a possible role of probiotics in vaginal infections resolution | Changes in clinical responses (absence of typical symptoms associated with vaginal infections) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events record | Assessed by CTCAE v4.0 | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics implementation, HPV infection, vaginosis, yeast vaginitis