Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676503
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2020-12-15
Brief Title:
Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of VaginitisVaginosis
Sponsor:
NTC srl
Organization:
NTC srl
Study Overview
Official Title:
Vaginal and Rectal Colonization of Lactobacillus Crispatus NTCVAG04 Following Oral Administration in Patients With History of VaginitisVaginosis
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 suppositoriesHowever 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 2017245 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 andor prevention of recurrences of vaginitisvaginosis
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 suppositoriesHowever 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 2017245 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 andor prevention of recurrences of vaginitisvaginosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None