[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacterial-vaginoses\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacterial-vaginoses":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100424510",false,"NCT04807842","Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis","A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis","Inclusion Criteria:\n\n* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\\>20%))\n* Women of childbearing potential\n* Aged \\>18 years\n* Signed written informed consent form\n* Willing to comply to the follow-up schedule\n\nExclusion Criteria:\n\n* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)\n* Presence of Trichomonas and\u002For Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)\n* Current genital malignancies\n* Chemotherapy for any reason in last 6 months\n* Radiotherapy in the genitourinary system in the last 12 months\n* Use of antibiotics for any reason in the last 14 days\n* Use of intravaginal devices during the investigation or in the last 14 days\n* Pregnancy or currently attempting to conceive\n* Lactation\n* Use of other treatment for vaginal conditions during the course of the clinical investigation\n* Known allergies to ingredients of the product\n* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation","FEMALE","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.\n\nTreatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.",[25],"Bacterial Vaginoses","RECRUITING","2025-09-23",{"date":29,"type":30},"2025-09-29","ACTUAL",{"date":32,"type":30},"2021-06-11",{"date":34,"type":19},"2026-12-01",{"name":36,"class":37},"BioClin BV","INDUSTRY",1,{"id":40,"slug":4,"hasResults":10,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":38},"100402225","NCT04517487","Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis","Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Ages 18-50\n* Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year.\n* Patients are otherwise healthy.\n* Contraception use\n\nExclusion Criteria:\n\n* Pregnancy or a planned pregnancy in the upcoming year\n* Infection with HIV.\n* Immunodeficiency status.","50 Years",{"count":47,"type":19},100,[22],"Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors \\[Lev-Sagie, Nature Medicine 2019\\]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission.\n\nThe proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.",[25],"2025-03-15",{"date":53,"type":30},"2025-03-19",{"date":55,"type":30},"2020-08-20",{"date":57,"type":19},"2026-12",{"name":59,"class":60},"Hadassah Medical Organization","OTHER",""]