[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550739":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":39,"locations":38,"responsibleParty":47,"collaborators":38,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":38,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":80,"whyStopped":38,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":38},{"fullName":5,"class":6},"NEXBIOME THERAPEUTICS","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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)",[13,14],"Drug: BGY-1601-VT","Other: PLACEBO",{"label":16,"type":10,"description":17,"interventionNames":18},"BGY-1601-VT #2","BGY-1601#2: one verum tablet at D0 and one verum tablet at D2",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"PLACEBO","PLACEBO_COMPARATOR","Placebo: one placebo tablet at D0 and one placebo tablet at D2",[14],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","BGY-1601-VT","Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.",[9,16],[31],"BGY-1601 vaginal tablet",{"type":33,"name":20,"description":34,"armGroupLabels":35,"otherNames":36},"OTHER","Placebo",[9,20],[37],"Placebo vaginal tablet",null,[40,44],{"name":41,"role":42,"phone":38,"phoneExt":38,"email":43},"Marine CARDONA","CONTACT","contact@nexbiome.com",{"name":45,"role":42,"phone":46,"phoneExt":38,"email":43},"Cyrille JEUNE","+33(0)772066938",{"type":48,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100550739","phase-1-efficacy-safety-and-dose-response-of-a-live-biotherapeutic-product-in-women-with-acute-vaginal-infection-100550739",false,"NCT06450990","Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection","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","ELINA","Inclusion Criteria:\n\n* Post-menarche woman aged 18 to 50 years old (inclusive),\n* With suspected Bacterial Vaginosis (BV) and\u002For Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection\n* No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,\n* Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,\n\nExclusion Criteria:\n\n* Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month\n* Current herpes simplex flare-up in the genital area,\n* Vulvar condyloma due to the human papilloma virus;\n* Vulvar dermatoses (e.g.: psoriasis or lichenification);\n* Clinical diagnosis of BV or VVC within 4 months;\n* Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;\n* Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;\n* Participant using any intravaginal product (local contraceptive \\[spermicide, hormonal ring\\], moisturizer, tampon, intimate hygiene product, etc.);\n* Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.\n* Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;\n* Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause;\n* With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;","FEMALE","18 Years","50 Years",{"count":61,"type":62},165,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","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",[69,70],"Bacterial Vaginosis","Vulvovaginal Candidiasis",[72,73,74,75,76,77,78,79],"Vaginal infection","Bacterial Vaginosis (BV)","Vulvovaginal Candidiasis (VVC)","Anaerobic bacteria","Prevotella","Gardnerella vaginalis","Candida albicans","Acute Vaginitis","NOT_YET_RECRUITING","2024-06-10",{"date":83,"type":84},"2024-06-12","ACTUAL",{"date":86,"type":62},"2024-07-08",{"date":88,"type":62},"2026-02-26",{"name":5,"class":6}]