Probiotic Implementation as Help in Solving Vaginal Infections

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372395
• Other study ID #: 3642
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2017
• Last updated: December 8, 2017
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• ASC-US
• Communicable Diseases
• Infection
• Vaginal Infection

Intervention

Other:
• Lactobacillus 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

References & Publications (1)

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):101-7. doi: 10.1007/s00404-015-3810-2. Epub 2015 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of a possible role of probiotics in vaginal infections resolution	Changes in clinical responses (absence of typical symptoms associated with vaginal infections)	9 months
Secondary	Treatment-related adverse events record	Assessed by CTCAE v4.0	9 months