A Phase 1 interventional study of Lcr Regenerans® vaginal capsules and Lcr Regenerans® vaginal tablet in Candidiasis, Vulvovaginal, sponsored by Biose. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Biose · Phase 1, Interventional, and Other
The primary objective of this study is to study the vaginal flora colonisation equivalence between the tablet and capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
The healthy vaginal microbiota is mainly colonised by strains of Lactobacillus which play an important role in defence against vaginal infections. The intravaginal use of probiotic strains stimulating the recolonisation of the endogenous vaginal microbiota and capable of inhibiting the growth of pathogens such as Candida albicans appears to be an interesting alternative to prevent recurrences of VVC. Recently, longitudinal studies have revealed that the vaginal microbiota is relatively stable and that the main cause of disturbance to the stability of the vaginal microbiota is over short menstruation periods. However, the use of antimicrobial agents induces severe disturbances with disappearance of certain endogenous species over several weeks. These results suggest that antimicrobial treatments severely affect the vaginal flora and that probiotics are therefore recommended to help re-establish a vaginal microbiota after this treatment.
For this, a sufficient direct local supply must be provided. The general data from studying the vaginal microbiota reveal that in the healthy woman, the concentration of Lactobacilli is greater than or equal to 107 CFU/ml of vaginal secretion. During capsule administration, all the Lactobacilli are immediately released into the vaginal cavity. The natural vaginal secretions, estimated to be an average of 0.51 ml/day, result in daily elimination of around 107 to 108 CFU and therefore generates very rapid elimination of this supply which requires daily administrations.
The objective of this clinical trial is to prove that the two dosage forms, capsule administered daily and tablet administered at a certain dosage, enable equivalent local provision of a concentration which is greater than or equal to 10e7 CFU (this concentration ensures the establishment of a sufficiently large bacterial population to enable efficacy of the product).
Therefore, the optimal dosage of the Lcr Regenerans® tablet to be administered and which will be equivalent to the daily administration of the Lcr Regenerans® capsule will be determined during this trial. To do this, 3 different dosages of the Lcr Regenerans® tablet, corresponding to or encompassing the time during which the tablet provides continuous release and presence of the strain in the in vitro model, will be compared to that of the Lcr Regenerans® capsule. For this reason, the frequencies of administration for the Lcr Regenerans® tablet will be 3, 4 or 5 days.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 34 is below the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Biose is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Relating to the condition:
Relating to the population:
Exclusion Criteria:
Relating to the treatments:
Relating to the population:
Name: Lcr Regenerans® containing at least 10e7 CFU per intravaginal capsule. 1 vaginal capsule per day
Device: Lcr Regenerans® vaginal capsules
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 3 days
Device: Lcr Regenerans® vaginal tablet
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 4 days
Device: Lcr Regenerans® vaginal tablet
Lcr Regenerans® containing at least 10e7 CFU per intravaginal table. One vaginal tablet every 5 days
Device: Lcr Regenerans® vaginal tablet
Also known as: GYNOPHILUS Capsules
Also known as: GYNOPHILUS Tablet
Measure the vaginal flora equivalence between the tablet and the capsule dosage forms of a treatment with Lcr Regenerans® between D0 (V1) and Dend of treatment.
Time frame: 21 days
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.