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

Launched by NEXBIOME THERAPEUTICS · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to evaluate a new treatment called BGY-1601-VT for women experiencing acute vaginal infections, specifically conditions like Bacterial Vaginosis (BV) and Vulvovaginal Candidiasis (VVC). The goal is to see how effective and safe this treatment is when used without needing a detailed lab diagnosis beforehand. The trial is currently not recruiting participants but will focus on women aged 18 to 50 who have symptoms of these infections.

To participate, women should not have recently been diagnosed with other infections or undergone certain treatments that could affect the results. They should also be healthy enough to take part in the study and be willing to follow the trial's guidelines. If eligible, participants will receive the new treatment and will be monitored for its effects on their infection. It’s important to know that women who are pregnant, breastfeeding, or going through menopause may not be able to join this trial. The findings could help improve future treatments for common vaginal infections.

Gender

FEMALE

Eligibility criteria

• 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;