[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NEXBIOME THERAPEUTICS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"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":20,"type":21},165,"ESTIMATED","INTERVENTIONAL",[24,25],"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",[28,29],"Bacterial Vaginosis","Vulvovaginal Candidiasis",[31,32,33,34,35,36,37,38],"Vaginal infection","Bacterial Vaginosis (BV)","Vulvovaginal Candidiasis (VVC)","Anaerobic bacteria","Prevotella","Gardnerella vaginalis","Candida albicans","Acute Vaginitis","NOT_YET_RECRUITING","2024-06-10",{"date":42,"type":43},"2024-06-12","ACTUAL",{"date":45,"type":21},"2024-07-08",{"date":47,"type":21},"2026-02-26",{"name":49,"class":50},"NEXBIOME THERAPEUTICS","INDUSTRY",""]