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