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

NCT06450990 | Not Yet Recruiting Phase 1

• 1 other identifier: BGY-1601-VT-001
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bacterial Vaginosis; Vulvovaginal Candidiasis

Keywords

Vaginal infection; Bacterial Vaginosis (BV); Vulvovaginal Candidiasis (VVC); Anaerobic bacteria; Prevotella; Gardnerella vaginalis; Candida albicans; Acute Vaginitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (3)

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)

Drug: BGY-1601-VT; Other: PLACEBO

BGY-1601-VT #2

EXPERIMENTAL

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

Drug: BGY-1601-VT

PLACEBO

PLACEBO COMPARATOR

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

Other: PLACEBO

Interventions

BGY-1601-VT DRUG

Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.

Also known as: BGY-1601 vaginal tablet

BGY-1601-VT #1; BGY-1601-VT #2

PLACEBO OTHER

Placebo

Also known as: Placebo vaginal tablet

BGY-1601-VT #1; PLACEBO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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;

Sponsors & Collaborators

• NEXBIOME THERAPEUTICS: lead

MeSH Terms

Conditions

Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Vaginitis

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Central Study Contacts

Marine CARDONA

CONTACT

contact@nexbiome.com

Cyrille JEUNE

CONTACT

+33(0)772066938; contact@nexbiome.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 10, 2024
• Study Start: July 8, 2024
• Primary Completion: December 28, 2025
• Study Completion: February 26, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share