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

ConditionsBacterial VaginosisVulvovaginal Candidiasis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNEXBIOME THERAPEUTICS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGY-1601-VT

    Drug

    Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.

  • PLACEBO

    Other intervention

    Placebo

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: BGY-1601-VT #1Experimental treatment 2 interventions
Group B: BGY-1601-VT #2Experimental treatment 1 intervention
Group C: PLACEBOPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NEXBIOME THERAPEUTICS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: