[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571871":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"S.I.I.T. Srl","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vagitab-T plus metronidazole (the standard treatment for bacterial vaginosis).","EXPERIMENTAL","Vagitab-T for 3 monthly cycles In addition, metronidazole (the standard treatment for bacterial vaginosis) will be administered for seven days.\n\nVagitab -T: 1.1 g vaginal tablets; medical device class IIa, already CE marked. The product contains the following components:\n\ntyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350\n\nMetronidazole It is the treatment indicated for Bacterial Vaginosis by the 2021 CDC's Sexually Transmitted Infections Treatment Guidelines.\n\nMetronidazole will be administered vaginally (as 500 mg vaginal ovules) or orally (as 500 mg tablets)",[13],"Device: Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:","Vagitab -T will be used for 3 monthly cycles of 10 days each. Metronidazole will be used for 1 cycle of 7 days at the start of the study\n\nMetronidazole will be administered as follows:\n\n500 mg intravaginally once per day for 7 days or 500 mg orally 2 times\u002Fday for 7 days",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Attila Fogarassy, MD","Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2 - Timisoara (Romania)","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Francesca Montarolo, MD","CONTACT","+39 02484352278","f.montarolo@siit-it.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Gyniclinique - Strada Johann Wolfgang von Goethe nr. 2","RECRUITING","Timișoara","Timiș County","300006","Romania","RO",{"type":42,"coordinates":43},"Point",[44,45],21.22571,45.75372,{"lat":45,"lon":44},[48,51],{"name":23,"role":29,"phone":49,"phoneExt":20,"email":50},"+40721136436","afogarassy@yahoo.com",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55],{"name":56,"class":57},"Opera CRO, a TIGERMED Group Company","OTHER","100571871","evaluation-of-the-medical-device-vagitab---t-as-adjuvant-therapy-in-patients-with-bacterial-vaginosis-100571871",false,"NCT06725888","Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.","A Prospective, Multicentre, Open-label, Study to Assess Performance and Safety of the Medical Device Vagitab - T in Rebalancing the Altered Vaginal Flora as Adjuvant Therapy in Patients With Bacterial Vaginosis and in Reducing Incidence of Recurrence During a 3-months Period of Follow-up.","Vagitab","Inclusion Criteria:\n\n* Female patients aged from 18 to 65 years (inclusive).\n* Patients affected at enrolment by BV diagnosed according to Amsel criteria, candidate to start an antibiotic therapy with metronidazole.\n* Patient with a medical history of RBV (at least 2 episodes of BV in the last 12 months including the current episode).\n* Patients who are, in the opinion of the Investigator, able to understand the study, cooperate with the study procedures and attend all the study visits.\n* Patients who have given their written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patient with a medical history of HIV or any other immunodeficiency.\n* Patients working as sex workers.\n* Patients with known allergies or intolerance \u002F hypersensitivity to the tested medical device and its components.\n* Patients with concomitant menstrual bleeding at baseline.\n* Time between the last day of last menses and treatment with metronidazole ≤ 3 days.\n* Pregnant, lactating, and lactating amenorrhoeic patients and patients of childbearing potential who are planning a pregnancy or unwilling to use appropriate methods of contraception during the study\n* Concomitant use of vaginal tampons.\n* Concomitant administration of etonogestrel\u002Fethinyl estradiol vaginal rings or of intrauterine devices.\n* Concomitant use of oral or vaginal antibiotic therapy (apart from metronidazole) or any other vaginal therapies or treatment (such as douching, spermicide).\n* Concomitant use of oral or vaginal probiotics.\n* Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.\n* Concomitant or previous (in the previous 30 days) participation in any other interventional clinical trials","FEMALE","18 Years","65 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.\n\nThe main goals of this trial are to see if the recurrence rate of bacterial vaginosis goes down during the study, if it helps balance the altered vaginal flora during antibiotic treatment, if it improves vaginal secretions, and if vaginal microflora return to normal. We'll also ask the participants about their quality of life and whether they think the treatment is safe.\n\nAll 30 women will get the same treatment, and there's no comparison group. They'll be treated with Vagitab-T vaginal tablets for three monthly cycles. Also, metronidazole will be taken at the start of the study for seven days.\n\nParticipants will sign an informed written consent and we'll visit them at the start (day 0) and end (day 90) of the study. In addition, we'll call them during each of the three cycles of treatment.",[77,78],"Bacterial Vaginosis (BV)","Recurrent Bacterial Vaginosis",[80,78,81,82],"Bacterial Vaginosis","Vaginal microflora","Lactobacillus","2025-05-21",{"date":85,"type":86},"2025-05-28","ACTUAL",{"date":88,"type":86},"2025-03-31",{"date":90,"type":71},"2025-09-30",{"name":5,"class":6},1]