Probiotic Implementation as Help in Solving Vaginal Infections
Primary Purpose
Vaginal Infection, ASC-US
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus rhamnosus BMX 54
Sponsored by
About this trial
This is an interventional supportive care trial for Vaginal Infection focused on measuring probiotics implementation, HPV infection, vaginosis, yeast vaginitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group 1
Group 2
Arm Description
Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
Outcomes
Primary Outcome Measures
Evaluation of a possible role of probiotics in vaginal infections resolution
Changes in clinical responses (absence of typical symptoms associated with vaginal infections)
Secondary Outcome Measures
Treatment-related adverse events record
Assessed by CTCAE v4.0
Full Information
NCT ID
NCT03372395
First Posted
November 14, 2017
Last Updated
December 8, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03372395
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infection, ASC-US
Keywords
probiotics implementation, HPV infection, vaginosis, yeast vaginitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
Intervention Type
Other
Intervention Name(s)
Lactobacillus rhamnosus BMX 54
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evaluation of a possible role of probiotics in vaginal infections resolution
Description
Changes in clinical responses (absence of typical symptoms associated with vaginal infections)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Treatment-related adverse events record
Description
Assessed by CTCAE v4.0
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26142892
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.
Results Reference
background
PubMed Identifier
29304768
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.
Results Reference
derived
Learn more about this trial
Probiotic Implementation as Help in Solving Vaginal Infections
We'll reach out to this number within 24 hrs