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

Phase 1

Not yet recruiting

• Conditions: Vulvovaginal Candidiasis; Bacterial Vaginosis
• Interventions: Other: PLACEBO; Drug: BGY-1601-VT

• Registration Number: NCT06450990
• Lead Sponsor: NEXBIOME THERAPEUTICS

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-10
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Study Start: 2024-07-08
• Primary Completion: 2025-12-28
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 165

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	PLACEBO	Placebo: one placebo tablet at D0 and one placebo tablet at D2
BGY-1601-VT #1	PLACEBO	Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
BGY-1601-VT #1	BGY-1601-VT	Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
BGY-1601-VT #2	BGY-1601-VT	BGY-1601#2: one verum tablet at D0 and one verum tablet at D2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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