Probiotic Implementation as Help in Solving Vaginal Infections

University of Roma La Sapienza

Status and phase: Completed; Phase 2

Conditions: Vaginal Infection; ASC-US

Treatments: Other: Lactobacillus rhamnosus BMX 54

Study type: Interventional

Funder types: Other

Identifiers

NCT03372395

3642

Details and patient eligibility

About

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.

Full 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).

Enrollment: 117 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Group 1

Other group

Description:

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

Treatment:

Other: Lactobacillus rhamnosus BMX 54

Group 2

Experimental group

Description:

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

Treatment:

Other: Lactobacillus rhamnosus BMX 54