ASC-US, Vaginal Infection
Conditions
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
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
Study design
Intervention model description
Pilot study
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of a possible role of probiotics in vaginal infections resolution | 9 months | Changes in clinical responses (absence of typical symptoms associated with vaginal infections) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events record | 9 months | Assessed by CTCAE v4.0 |