NCT06450990

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: NEXBIOME THERAPEUTICS · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-08
• Primary completion: 2025-12-28
• Completion: 2026-02-26
• First posted: 2024-06-10
• Last updated: 2024-06-12