Bacterial Vaginosis, Vulvovaginal Candidiasis
Conditions
Keywords
Vaginal infection, Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), Anaerobic bacteria, Prevotella, Gardnerella vaginalis, Candida albicans, Acute Vaginitis
Brief summary
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
Interventions
DRUGBGY-1601-VT
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
OTHERPLACEBO
Placebo
Sponsors
NEXBIOME THERAPEUTICS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Post-menarche woman aged 18 to 50 years old (inclusive), * With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection * No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination, * Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,
Exclusion criteria
* Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month * Current herpes simplex flare-up in the genital area, * Vulvar condyloma due to the human papilloma virus; * Vulvar dermatoses (e.g.: psoriasis or lichenification); * Clinical diagnosis of BV or VVC within 4 months; * Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication; * Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication; * Participant using any intravaginal product (local contraceptive \[spermicide, hormonal ring\], moisturizer, tampon, intimate hygiene product, etc.); * Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc. * Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months; * Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause; * With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection | Visit 2 (V2) = 7 days | Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Visit 2 (7 days) and Visit 3 (28 days) | Percentage of responders with clinical cure at each timepoints without rescue therapy Percentage of participants with improved symptoms at the timepoints |
| To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and | V2 (7 days) and V3 (28 days) | Adverse Events (AEs) reported |
| To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2. | Visit 2 (7 days) and Visit 3 (28 days) | quantitative Polymerase Chain Reaction (qPCR) Lcr35 in the vaginal microbiota |
Contacts
Primary ContactMarine CARDONA
Backup ContactCyrille JEUNE
Outcome results
None listed