Efficacy, safety, and dose-response of a Live Biotherapeutic Product (BGY-1601-VT, vaginal tablet) as a first-line monotherapy in women with acute vaginal infection: a randomized, double-blind, placebo-controlled study

Phase 1

• Conditions: Gynaecological; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-508958-26-00
• Lead Sponsor: exbiome Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-29
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 165

Inclusion Criteria

I1.Post-menarche / premenopausal women aged 18 to 50 years old (inclusive), I2.With suspected BV and/or VVC, presenting at least two of the following symptoms of acute vaginal infection: Fluid abundant discharge, thick abundant discharge, fishy odor, external (vulvar) or internal (vaginal) itching, external (vulvar) or internal (vaginal) burning., I3.Women not at risk of pregnancy., I4.Negative pregnancy urinary test performed during the screening visit., I5.Good general and mental health in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination., I6.Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form., I7.Affiliated with a health insurance through a public or private health insurance provider.

Exclusion Criteria

E1.Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month., E10.Participant who had a sexual intercourse from 48h prior to D0, or who is planning to have a sexual intercourse from V1 to V2, or within 48h prior to V3., E11.Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc., E12.Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months., E13. Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause., E14.With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient., E15.Taking part in another clinical trial or being in the exclusion period of a previous clinical trial., E16.Under legal protection (guardianship, wardship) or deprived from her rights following administrative or judicial decision., E17.Presenting a psychological or linguistic incapability to sign the informed consent., E18.Impossible to contact in case of emergency., E2.Current herpes simplex flare-up in the genital area., E3.Vulvar condyloma due to the human papilloma virus., E4.Vulvar dermatoses (e.g.: psoriasis or lichenification)., E5.Clinical diagnosis of BV or VVC within 4 months., E6.Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months , regardless of the indication., E7.Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication., E8. Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.)., E9.Participant who is likely to be menstruating between D0 and D4.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to compare the efficacy of BGY-1601-VT, according to the dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection :<br>- 7 days (-1/+3) after treatment start (V2)<br>- In women with confirmed diagnosis of Bacterial Vaginosis (BV), Vulvovaginal Candidiadis (VVC), or mixed infection (BV+VCC).;Secondary Objective: 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., To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimen #2, and the safety of placebo., To compare the evolution of Lacticaseibacillus rhamnosus Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.;Primary end point(s): Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.