Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04676503 |
| Other study ID # |
NTCVAG04_02-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 22, 2019 |
| Est. completion date |
July 21, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
NTC srl |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to identify the presence of L. Crispatus in the rectum and
vagina after oral administration of BIOVAGINIL by searching for specific DNA of the bacterial
strain, to evaluate the tolerability of BIOVAGINIL and evaluate the minimum duration of the
oral administration necessary to determine the appearance of L. Crispatus.
Description:
In fertile, premenopausal healthy women, the vaginal ecosystem is dominated by Lactobacillus
spp., but a diverse array of other bacteria can be present in much lower numbers. Over 120
species of Lactobacillus have been identified and more than 20 species have been detected in
the vagina. Molecular-based techniques have demonstrated that healthy vaginal microflora does
not contain high numbers of many different species of Lactobacillus. Rather, one or two
lactobacilli from a range of three or four species (mainly L. crispatus and L. iners but also
L. jensenii and L. gasseri) are dominant, whereas other species are rare, lower in titer and
tend to be novel phylotypes.
Vaginitis is defined as a spectrum of conditions that cause vaginal and sometimes vulvar
symptoms such as itching, burning, irritation, odor and vaginal discharge. Infection is the
most common cause of vaginitis, including bacterial vaginosis (BV), vulvovaginal candidiasis
and trichomoniasis. Bacterial vaginosis is a very common microbiological disturbance of the
vaginal environment in adult women and is characterized by a depletion of lactobacilli in
favor of an overgrowth of anaerobic bacteria. Colonization by L. crispatus or L. jensenii is
associated with a lower frequency of bacterial vaginosis, and L. crispatus is strongly
correlated with the absence of BV, low pH, negative whiff test, absence of clue cells and
normal vaginal discharge.
Although antibiotic treatment of BV is strongly recommended, attempts at improving the
efficacy of therapy are still a matter of debate. In fact, antimicrobial treatment of
urogenital infections is not always effective, and problems remain due to bacterial and yeast
resistance, recurrent infections and side effects. Alternative remedies are thus of interest
and many studies have provided evidence of the beneficial functions of the human microbiota
and prompted the selection of bacterial strains with health-promoting capacities for the
treatment of conditions in which the microbiota, or its optimal functioning, is altered. The
rationale for the use of probiotics in women is based on the genitourinary regulatory role
played by the healthy vaginal microbiota and the need for restoration of this microbial
ecosystem after insult.
Until today, the most common way of delivering probiotic lactobacilli was the administration
of vaginal suppositories.However, this route will no longer be acceptable as products
containing probiotics (live microorganisms) are not admissible as medical devices as per
European Medical Device Regulation (EU) 2017/245. Oral administration therefore represents an
alternative and more patient-friendly concept for the restitution of the normal vaginal
microbiota. Indeed, several studies demonstrated the ability of rectal bacteria to move from
the intestinal tract to the vagina. Moreover, it was recently demonstrated that the
administration of a yoghurt containing Lactobacillus spp. including L.. crispatus in addition
to antibiotic treatment may improve recovery rate and symptoms of BV and is well tolerated.
It is therefore reasonable to suppose that the oral administration of a food supplement
containing an adequate concentration of a strain of L. crispatus, one of the predominant
species, in the vaginal microbiota in asymptomatic women, may promote the re-colonization of
the vaginal environment. Since this species is so representative and crucial in maintaining a
healthy vaginal environment, we believe that it is of utter importance to understand its
activity to fully disclose its potential.
The aim of this pilot study is to investigate the presence of Lactobacillus crispatus
NTCVAG04 in the vagina after oral administration of BIOVAGINIL, a food supplement, as a
precondition for the subsequent evaluation of the ability of NTCVAG04 to rebalance the local
microbiota and promote healing and/or prevention of recurrences of vaginitis/vaginosis.
