[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640908":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":22,"locations":31,"responsibleParty":64,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":11,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Bioithas SL","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bioithas WOMAN®","EXPERIMENTAL",null,[13],"Dietary Supplement: Bioithas WOMAN®",{"label":15,"type":16,"description":11,"interventionNames":11},"Control group","NO_INTERVENTION",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":11},"DIETARY_SUPPLEMENT","≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus",[9],[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Juan Gabriel Agüera Santos","CONTACT","623 02 25 86","juan.aguera@bioithas.com",{"name":29,"role":25,"phone":11,"phoneExt":11,"email":30},"Vicente Navarro López","vicente.navarrro@bioithas.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital Universitario de Torrevieja","RECRUITING","Torrevieja","Alicante","03186","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-0.68222,37.97872,{"lat":44,"lon":43},[47,51,54,57,60,62],{"name":48,"role":25,"phone":49,"phoneExt":11,"email":50},"Ana María Navarro Fenoll","608 33 07 27","navarro_anafen@gva.es",{"name":52,"role":25,"phone":11,"phoneExt":11,"email":53},"Eduardo Cazorla Amorós","cazorla_edu@gva.es",{"name":55,"role":56,"phone":11,"phoneExt":11,"email":11},"Eduardo Cazorla Amorós, MD","PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},"Duska Beric, MD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":11,"phoneExt":11,"email":11},"Elisa Peñalver Escolano, MD",{"name":63,"role":59,"phone":11,"phoneExt":11,"email":11},"Ana María Navarro Fenoll, SN",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640908","evaluation-of-the-efficacy-of-a-probiotic-product-as-an-adjuvant-treatment-for-vulvovaginal-candidiasis-100640908",false,"NCT07603895","Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis","Inclusion Criteria:\n\n* Women of reproductive age who use effective contraceptive methods during the course of the study.\n* Clinical suspicion of vulvovaginal candidiasis, in the investigator's judgment, based on the presence of symptoms - e.g., pruritus, burning sensation, irritation, dyspareunia and\u002For abnormal vaginal discharge - and\u002For compatible clinical findings.\n* Possibility of collecting a vaginal sample at the baseline visit for microbiological analysis.\n* Ability and willingness to comply with the study procedures and to sign the informed consent form\n\nExclusion Criteria:\n\n* Menstruation at the time of inclusion.\n* Pregnancy or breastfeeding.\n* Menopause or perimenopause.\n* Diabetes mellitus.\n* Presence of immunocompromised status or treatment with immunosuppressants within the 3 months prior to inclusion in the trial.\n* Vaginal coinfection in addition to vulvovaginal candidiasis.\n* Severe chronic diseases or other active infections that may interfere with the clinical assessment of vulvovaginal candidiasis, in the investigator's judgment.\n* History of intolerance or hypersensitivity to the intervention products.\n* Treatment with antifungals or probiotic supplements in the month prior to inclusion in the trial.","FEMALE",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).\n\nAll participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic group will additionally receive Bioithas WOMAN®, supplied as a bottle containing 30 capsules, to be taken during the 4-week intervention period.\n\nThe study includes two on-site visits: Visit 1 (baseline) and Visit 2 (week 4\u002Fend of study). At baseline, demographic data, relevant gynecological history, VVC risk factors, clinical characteristics of the current episode, concomitant diseases, and usual pharmacological treatments will be recorded. Clinical symptoms associated with VVC, including abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia, will be assessed, together with the Vaginitis Symptom Score (VSS).\n\nAt both visits, vaginal pH will be measured using an indicator strip applied to the vaginal mucosa. A vaginal sample will also be collected using a sterile swab for microbiological culture of Candida and semiquantitative assessment of Lactobacillus. Although randomization will be performed in women with clinical suspicion of VVC, microbiological confirmation by culture will be obtained after inclusion.\n\nAt the final visit, the same clinical and microbiological variables will be reassessed. Concomitant treatments, relevant follow-up observations, and any adverse events reported during the study will also be recorded. In the probiotic group, adherence to treatment will be assessed by counting the remaining capsules.",[81],"Vulvovaginal Candidiasis (VVC)","2026-05-18",{"date":84,"type":85},"2026-05-22","ACTUAL",{"date":87,"type":75},"2026-05-25",{"date":89,"type":75},"2026-12-31",{"name":5,"class":6},1]