- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372395
Probiotic Implementation as Help in Solving Vaginal Infections
December 8, 2017 updated by: Pierluigi Benedetti Panici, University of Roma La Sapienza
Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 1
Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
|
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).
|
Experimental: Group 2
Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of a possible role of probiotics in vaginal infections resolution
Time Frame: 9 months
|
Changes in clinical responses (absence of typical symptoms associated with vaginal infections)
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related adverse events record
Time Frame: 9 months
|
Assessed by CTCAE v4.0
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
November 14, 2017
First Submitted That Met QC Criteria
December 8, 2017
First Posted (Actual)
December 13, 2017
Study Record Updates
Last Update Posted (Actual)
December 13, 2017
Last Update Submitted That Met QC Criteria
December 8, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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