Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
NCT ID: NCT06450990
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
165 participants
INTERVENTIONAL
2024-07-08
2026-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BGY-1601-VT #1
Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
BGY-1601-VT
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
PLACEBO
Placebo
BGY-1601-VT #2
BGY-1601#2: one verum tablet at D0 and one verum tablet at D2
BGY-1601-VT
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
PLACEBO
Placebo: one placebo tablet at D0 and one placebo tablet at D2
PLACEBO
Placebo
Interventions
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BGY-1601-VT
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
PLACEBO
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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,
Exclusion Criteria
* 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;
* 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;
18 Years
50 Years
FEMALE
No
Sponsors
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NEXBIOME THERAPEUTICS
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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BGY-1601-VT-001
Identifier Type: -
Identifier Source: org_study_id
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