NCT03372395

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

November 14, 2017

Last Update Submit

December 8, 2017

Conditions

Vaginal InfectionASC-US

Keywords

probiotics implementationHPV infectionvaginosisyeast vaginitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Treatment-related adverse events record

    9 months

Study Arms (2)

Group 1

OTHER

Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation

Other: Lactobacillus rhamnosus BMX 54

Group 2

EXPERIMENTAL

Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration

Other: Lactobacillus rhamnosus BMX 54

Interventions

Lactobacillus rhamnosus BMX 54OTHER

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).

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy or breastfeeding
  • previous abnormal PAP-smear
  • CIN2-3
  • concomitant malignancies
  • immunological diseases
  • severe comorbidities
  • prolonged corticosteroid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26142892BACKGROUND

  • 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.

    PMID: 29304768DERIVED

MeSH Terms

Conditions

VaginitisAtypical Squamous Cells of the CervixPapillomavirus InfectionsVaginal DiseasesCandidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine Cervical DysplasiaPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and SymptomsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesCandidiasisMycosesBacterial Infections and MycosesVulvovaginitisVulvitisVulvar Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor and Director of Dept Obstetrics and Gynecology

Study Record Dates

First Submitted

November 14, 2017

First Posted

December 13, 2017

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

December 13, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share