Clinical trial NCT03372395: Probiotic Implementation as Help in Solving Vaginal Infections
Official title: Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaginal Infection
ASC-US
Keywords: probiotics implementation
HPV infection
vaginosis
yeast vaginitis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pilot study
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of a possible role of probiotics in vaginal infections resolution
timeFrame: 9 months
Secondary outcomes:
measure: Treatment-related adverse events record
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
citation: Recine N, Palma E, Domenici L, Giorgini M, Imperiale L, Sassu C, Musella A, Marchetti C, Muzii L, Benedetti Panici P. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis. Arch Gynecol Obstet. 2016 Jan;293(1):101-107. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5.
citation: Palma E, Recine N, Domenici L, Giorgini M, Pierangeli A, Panici PB. Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection. BMC Infect Dis. 2018 Jan 5;18(1):13. doi: 10.1186/s12879-017-2938-z.