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NOT YET RECRUITING
NCT06450990
PHASE1/PHASE2

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

Sponsor: NEXBIOME THERAPEUTICS

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2024-07-08

Completion Date

2026-02-26

Last Updated

2024-06-12

Healthy Volunteers

No

Interventions

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