Bacterial VaginosisPhase 1/2ELINANCT06450990
Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
A Phase 1/2 study testing BGY-1601-VT in people with Bacterial Vaginosis and Vulvovaginal Candidiasis, run by NEXBIOME THERAPEUTICS.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Vulvovaginal Candidiasis
- What is being tested?
- BGY-1601-VT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2024to 26 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- 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;
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- 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;
Trial locations and contacts
No sites are listed yet.
Marine CARDONA contact
About this study
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
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
- Being tested
- BGY-1601-VT, PLACEBO
- Keywords
- Vaginal infection, Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), Anaerobic bacteria, Prevotella, Gardnerella vaginalis, Candida albicans, Acute Vaginitis
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGY-1601-VTDrug
Also called BGY-1601 vaginal tablet
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
PLACEBOOther
Also called Placebo vaginal tablet
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BGY-1601-VT #1 | Experimental | Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2) Receives: Drug: BGY-1601-VT; Other: PLACEBO |
| BGY-1601-VT #2 | Experimental | BGY-1601#2: one verum tablet at D0 and one verum tablet at D2 Receives: Drug: BGY-1601-VT |
| PLACEBO | Placebo comparator | Placebo: one placebo tablet at D0 and one placebo tablet at D2 Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 2 (V2) = 7 days
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Visit 2 (7 days) and Visit 3 (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start8 Jul 2024 (estimated)
- Primary completion28 Dec 2025 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical trial is an Interventional, phase I-II, randomized, double-blind, parallel assignment, placebo-controlled, multiple-dosing regimen. The hypothesis of the trial is the superiority of the active treatment (dose #1 and/or dose #2) versus the placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEXBIOME THERAPEUTICS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450990
- Sponsor's protocol ID
- BGY-1601-VT-001
- Acronym
- ELINA
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06450990
- Acronym / sponsor ID
- ELINA / BGY-1601-VT-001
- Conditions
- Bacterial Vaginosis, Vulvovaginal Candidiasis
- Keywords
- Vaginal infection, Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), Anaerobic bacteria, Prevotella, Gardnerella vaginalis, Candida albicans, Acute Vaginitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- NEXBIOME THERAPEUTICSIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (estimated)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This clinical trial is an Interventional, phase I-II, randomized, double-blind, parallel assignment, placebo-controlled, multiple-dosing regimen. The hypothesis of the trial is the superiority of the active treatment (dose #1 and/or dose #2) versus the placebo.
| Arm | Type | Receives |
|---|---|---|
| BGY-1601-VT #1 | Experimental | Drug: BGY-1601-VT, Other: PLACEBOArm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2) |
| BGY-1601-VT #2 | Experimental | Drug: BGY-1601-VTBGY-1601#2: one verum tablet at D0 and one verum tablet at D2 |
| PLACEBO | Placebo comparator | Other: PLACEBOPlacebo: one placebo tablet at D0 and one placebo tablet at D2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGY-1601-VTAlso: BGY-1601 vaginal tabletLive biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35. | Drug | BGY-1601-VT #1, BGY-1601-VT #2 |
| PLACEBOAlso: Placebo vaginal tabletPlacebo | Other | BGY-1601-VT #1, PLACEBO |
Primary outcome
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
Time frame: Visit 2 (V2) = 7 days
Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy
3 secondary outcomes
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
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
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.
Time frame: Visit 2 (7 days) and Visit 3 (28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marine CARDONA contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BGY-1601-VT in people with Bacterial Vaginosis and Vulvovaginal Candidiasis, run by NEXBIOME THERAPEUTICS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine CARDONA (contact@nexbiome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection (time frame: Visit 2 (V2) = 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.