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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
165
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
Placebo
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy
Time frame: Visit 2 (V2) = 7 days
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
Percentage of responders with clinical cure at each timepoints without rescue therapy Percentage of participants with improved symptoms at the timepoints
Time frame: Visit 2 (7 days) and Visit 3 (28 days)
To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and
Adverse Events (AEs) reported
Time frame: V2 (7 days) and V3 (28 days)
To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.
quantitative Polymerase Chain Reaction (qPCR) Lcr35 in the vaginal microbiota
Time frame: Visit 2 (7 days) and Visit 3 (28 days)
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