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Probiotic Implementation as Help in Solving Vaginal Infections

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03372395
Enrollment
117
Registered
2017-12-13
Start date
2015-02-28
Completion date
2016-04-30
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASC-US, Vaginal Infection

Keywords

probiotics implementation, HPV infection, vaginosis, yeast vaginitis

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.

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).

Interventions

OTHERLactobacillus 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).

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Pilot study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Exclusion criteria

* pregnancy or breastfeeding * previous abnormal PAP-smear * CIN2-3 * concomitant malignancies * immunological diseases * severe comorbidities * prolonged corticosteroid treatment.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of a possible role of probiotics in vaginal infections resolution9 monthsChanges in clinical responses (absence of typical symptoms associated with vaginal infections)

Secondary

MeasureTime frameDescription
Treatment-related adverse events record9 monthsAssessed by CTCAE v4.0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026