[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566761":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":41,"locations":47,"responsibleParty":67,"collaborators":32,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":32,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":32,"maxAge":32,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Hasanuddin University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the treatment group and will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.",[13],"Dietary Supplement: Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This group consist of postmenopausal women diagnosed with bacterial vaginosis. All subjects will receive metronidazole oral 400-500 mg twice daily or 0,75% metronidazole gel 5 grams intravaginally once daily for 5 days, then blind-randomly including to the placebo group and will receive Cal95® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.",[19],"Dietary Supplement: Metronidazole + Cal95",{"label":21,"type":22,"description":23,"interventionNames":24},"Control","ACTIVE_COMPARATOR","This group consist of postmenopausal women with no bacterial vaginosis. All subjects will receive Floragyn® probiotic tablets (Lapi, Indonesia) orally once daily for two weeks.",[25],"Dietary Supplement: Floragyn® probiotic tablets (Lapi, Indonesia)",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Metronidazole + Floragyn® probiotic tablets (Lapi, Indonesia)","Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis.\n\nOne tablet Floragyn contains Lactobacillus rhamnosus and lactobacillus reuteri, bacteria that are normal flora (good bacteria) of the vagina.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Metronidazole + Cal95","Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis.\n\nCal 95 is a supplement containing multivitamins and minerals including: Calcium, Zinc, Boron and Magnesium. This tablet is used to help meet calcium needs and maintain bone health in menopausal women.",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Floragyn® probiotic tablets (Lapi, Indonesia)","Given to the control group to ensure the ability of probiotics to maintain a healthy vaginal ecosystem and not the opposite.",[21],[42],{"name":43,"role":44,"phone":45,"phoneExt":32,"email":46},"Yenti Purnamasari","CONTACT","+628114058258","yenti.purnamasari@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Alfa Farma Health Clinic, Obstetrics and Gynecology Doctor's Practice.","RECRUITING","Kendari","South East Sulawesi","93117","Indonesia","ID",{"type":57,"coordinates":58},"Point",[59,60],122.51507,-3.9778,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":65,"phoneExt":32,"email":66},"Juminten Sp.OG(K), Professor","+6282197276207","inten_azis@yahoo.com",{"type":68,"investigatorFullName":43,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100566761","probiotic-efficacy-in-postmenopausal-women-with-bacterial-vaginosis-100566761",false,"NCT06659380","Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis","Modulation of Vaginal Microbiota by Lactobacillus Sp As a Probiotic and Immunomodulatory Agent in Postmenopausal Women with Bacterial Vaginosis","Inclusion Criteria:\n\n1. Postmenopausal with estradiol levels \\\u003C 25 mg\u002Fml\n2. Diagnosed have bacterial vaginosis by an obstetrician and gynecologist\n\nExclusion Criteria:\n\n1. Medically unable to perform a pap smear examination\n2. Experiencing vaginal bleeding of unknown cause\n3. Diagnosed or suspected of having a malignant disease\n4. Hypersensitivity to the research treatment to be carried out\n5. In the last 3 months have received hormone therapy\n6. Suffering from acute infectious diseases of the genital organs\n7. Using vaginal therapy in any form\n8. Suffering from systemic diseases",true,"FEMALE",{"count":80,"type":81},12,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.",[87,88],"Bacterial Vaginosis (BV)","Menopause",[90],"NO","2024-10-24",{"date":93,"type":94},"2024-10-28","ACTUAL",{"date":96,"type":94},"2024-06-26",{"date":98,"type":81},"2024-12-31",{"name":5,"class":6},1]