Clinical trial NCT06450990: Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
Official title: Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bacterial Vaginosis
Vulvovaginal Candidiasis
Keywords: Vaginal infection
Bacterial Vaginosis (BV)
Vulvovaginal Candidiasis (VVC)
Anaerobic bacteria
Prevotella
Gardnerella vaginalis
Candida albicans
Acute Vaginitis
Lead sponsor: NEXBIOME THERAPEUTICS
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
timeFrame: Visit 2 (V2) = 7 days
Secondary outcomes:
measure: 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
timeFrame: Visit 2 (7 days) and Visit 3 (28 days)
measure: To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and
timeFrame: V2 (7 days) and V3 (28 days)
measure: To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.
timeFrame: Visit 2 (7 days) and Visit 3 (28 days)
Other outcomes:
Locations:
Study officials:
References: