Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection (ELINA)

NEXBIOME THERAPEUTICS

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Vulvovaginal Candidiasis; Bacterial Vaginosis

Treatments: Drug: BGY-1601-VT; Other: PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT06450990

BGY-1601-VT-001

Details and patient eligibility

About

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

Enrollment: 165 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups, including a placebo group

BGY-1601-VT #1

Experimental group

Description:

Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)

Treatment:

Other: PLACEBO

Drug: BGY-1601-VT

BGY-1601-VT #2

Experimental group

Description:

BGY-1601#2: one verum tablet at D0 and one verum tablet at D2

Treatment:

Drug: BGY-1601-VT

PLACEBO

Placebo Comparator group

Description:

Placebo: one placebo tablet at D0 and one placebo tablet at D2

Treatment:

Other: PLACEBO