Probiotic Implementation as Help in Solving Vaginal Infections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginal Infection ASC-US Atypical Squamous Cells of the Cervix Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Morphological and Microscopic Findings Mycoses Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Vaginal Diseases Vaginitis Virus Diseases Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus rhamnosus BMX 54

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).

Primary outcomes

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 outcomes

Treatment-related adverse events record

Time frame: 9 months

Assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Dec 13, 2017
Registry last updated: Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed