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The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGY-1601-VT #1 | Experimental | Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2) |
|
| BGY-1601-VT #2 | Experimental | BGY-1601#2: one verum tablet at D0 and one verum tablet at D2 |
|
| PLACEBO | Placebo Comparator | Placebo: one placebo tablet at D0 and one placebo tablet at D2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGY-1601-VT | Drug | Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection | Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy | Visit 2 (V2) = 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo, dosing regimen #2 versus placebo, and dosing regimen #1 versus dosing regimen #2, to treat acute vaginal infection | Percentage of responders with clinical cure at each timepoints without rescue therapy Percentage of participants with improved symptoms at the timepoints | Visit 2 (7 days) and Visit 3 (28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marine CARDONA | Contact | contact@nexbiome.com | ||
| Cyrille JEUNE | Contact | +33(0)772066938 | contact@nexbiome.com |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002181 | Candidiasis, Vulvovaginal |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014623 | Vaginal Diseases |
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This clinical trial is an Interventional, phase I-II, randomized, double-blind, parallel assignment, placebo-controlled, multiple-dosing regimen. The hypothesis of the trial is the superiority of the active treatment (dose #1 and/or dose #2) versus the placebo.
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| PLACEBO | Other | Placebo |
|
|
| To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and | Adverse Events (AEs) reported | V2 (7 days) and V3 (28 days) |
| To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2. | quantitative Polymerase Chain Reaction (qPCR) Lcr35 in the vaginal microbiota | Visit 2 (7 days) and Visit 3 (28 days) |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |