Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-09 @ 11:03 PM
Study NCT ID:
NCT02730494
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Optimal Dosage for Equivalence Between Lcr Regenerans® Capsules and Tablets (Lactobacillus Rhamnosus Lcr35®) on the Vaginal Flora Colonisation
Sponsor:
Biose
Organization:
Study Overview
Official Title:
Study Evaluating the Optimal Dosage for Equivalence Between a Tablet and Capsule Dosage Form of an Intravaginal Treatment With Total Freeze-dried Culture of Lcr Regenerans® (Lactobacillus Rhamnosus Lcr35®) on Vaginal Flora Colonisation in Healthy Women.
Status:
COMPLETED
Status Verified Date:
2018-02
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:
COMPRIGEL
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-001746-21 | EUDRACT_NUMBER | None | View |