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

Bacterial Vaginosis Clinical Trial

— ELINA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450990
• Other study ID #: BGY-1601-VT-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 8, 2024
• Est. completion date: February 26, 2026

Study information

• Verified date: June 2024
• Source: NEXBIOME THERAPEUTICS
• Contact: Marine CARDONA
• Email: contact[@]nexbiome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: February 26, 2026
• Est. primary completion date: December 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Candidiasis, Vulvovaginal
• Infections
• Vaginal Diseases
• Vaginosis, Bacterial
• Vulvovaginal Candidiasis

Intervention

Drug:
• BGY-1601-VT
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.

Other:
• PLACEBO
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NEXBIOME THERAPEUTICS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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)
Secondary	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)
Secondary	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)