[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacterial-vaginosis-bv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacterial-vaginosis-bv":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,70,99],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100633506","phase-2-study-to-evaluate-efficacy-and-safety-of-gyntima-balance-in-preventing-recurrences-of-bacterial-vaginosis-100633506",false,"NCT07527572","Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis.","GYNBAL-RBV","Inclusion Criteria:\n\n* Females of ages 18-45 years (both values included) who are premenopausal.\n* History of recurrent BV (at least 3 episodes in the last 12 months with at least one of them documented in the last 6 months).\n* Positive Amsel's criteria (confirming active BV) determined by at least 3 out of the following 4 symptoms or signs:\n\n  * Homogeneous, thin, yellowish-white\u002Fgreyish white discharge that smoothly coats the vaginal walls.\n  * Presence of the clue cells on microscopic examination (as assessed by wet mount test).\n  * A fishy odor of vaginal discharge after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as \"whiff test\".\n  * Vaginal pH \\> 4.5\n* Imbalance in vaginal pH (pH \\> 4.5).\n* Participants with Body Mass Index (BMI) 18.5-32.0 kg\u002Fm2.\n* Non-smokers.\n* Participants able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood and urine sample collection procedures and study visit schedule).\n* Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.\n* Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.\n\nExclusion Criteria:\n\n* Participants currently taking contraceptives and\u002For sexual hormones.\n* Pregnant or breastfeeding.\n* Menstrual period expected within the next 6 days of screening.\n* Irregular cycle (\"irregular\" (e.g., less than 21 or more than 35 days consistently, or cycle variability more than 4 days month-to-month).\n* Participants who have documented resistance to metronidazole.\n* Participants diagnosed with any vaginal or urinary tract infection other than BV.\n* Participants who have used other probiotics or antibiotics (vaginal, oral, parenteral) in the last 15 days.\n* Participants using other vaginal products with bacteriostatic or bactericide activity (such as lactic acid gels, herbal extracts, dequalinum chloride, etc.).\n* Participants with an intrauterine contraceptive device (IUCD\u002FIUD) in situ at screening.\n* Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.\n* Women diagnosed with Sexually transmitted infections (STIs) or Human immunodeficiency virus (HIV) infection.\n* Participants diagnosed with Polycystic ovary syndrome (PCOS) or other such diseases that further affect the hormonal homeostasis in women.\n* Presence of uncontrolled diabetes mellitus (Indicated by Fasting Blood Glucose (FBG) more than or equal to 126 mg\u002FdL. Fasting is defined as no caloric intake for at least 8 hours).\n* Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) more than or equal to 140 mm Hg and\u002For Diastolic Blood Pressure (DBP) more than or equal to 90 mm Hg).\n* Untreated previously diagnosed thyroid disorders.\n* Participants who have a history of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.\n* Participation in other clinical trials in last 3 months prior to screening.\n* Participants with substance abuse problems defined as:\n\n  * High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any Day or 8 or more alcohol containing beverages per week for women.\n* Participants who have any of the following clinically significant illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, chronic gastrointestinal diseases, etc.\n* Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.","FEMALE","18 Years","45 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections. Bacterial vaginosis (BV) is the most common vaginal imbalance in women of reproductive age, caused by depletion of protective Lactobacillus species and overgrowth of anaerobic bacteria such as Gardnerella vaginalis. BV affects an estimated 23-29 percentage of women globally (10-30 percentage in India) and is associated with discharge, odor, discomfort, and significant risks including recurrent disease, adverse reproductive outcomes, and increased susceptibility to STIs. Although antibiotics are effective for acute treatment, recurrence rates are high (50-60 percentage within 12 months), highlighting an unmet need for preventive strategies.\n\nProbiotics, particularly Lactobacillus species, have emerged as promising options to restore vaginal microbiota balance and reduce BV recurrence. Lactobacillus gasseri is a natural vaginal commensal with antimicrobial activity against BV pathogens and the ability to lower vaginal pH. L. gasseri KABP®064 has demonstrated vaginal colonization after oral administration, good tolerability, and potential to promote vaginal health.\n\nThe present randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of oral L. gasseri KABP®064 in preventing BV recurrence over six months following standard antibiotic therapy. Outcomes include recurrence rates and timing, symptom severity, microbiological balance, inflammation markers, and patient-reported vaginal health, supporting a microbiome-focused, non-antibiotic approach to BV recurrence prevention.",[29,30,31],"Vaginosis, Bacterial","Bacterial Vaginosis","Bacterial Vaginosis (BV)",[33,34,35,30],"Recurrence","Microbiome","Metronidazole","NOT_YET_RECRUITING","2026-04-09",{"date":39,"type":40},"2026-04-14","ACTUAL",{"date":42,"type":22},"2026-04-01",{"date":44,"type":22},"2027-10-01",{"name":46,"class":47},"Kaneka Americas Holding Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100629998","phase-2-chlorhexidine-andor-metronidazole-plus-fb301-pre-treatment-trial-100629998","NCT07481955","Chlorhexidine and\u002For Metronidazole Plus FB301 Pre-treatment Trial","Open-label Safety and Efficacy Trial of Chlorhexidine and\u002For Metronidazole Pre-treatment Followed by FB301 in Women With Bacterial Vaginosis","1. Premenopausal women aged 18 to 45 years of age inclusive, at the time of signing the informed consent.\n2. Participants with an untreated suspected or confirmed symptomatic BV presenting with characteristic vaginal discharge and\u002For fishy odor confirmed by Gram stain of the vaginal specimen having a Nugent Score of equal or above 7 at the screening visit.\n3. Participant is otherwise in good physical and mental health, as determined by the investigator\n4. BMI up to 37 kg\u002Fm2 (inclusive)\n5. Premenopausal female patients Using oral, transdermal (patches), or injectable\u002Fimplantable contraceptives or hormonal IUS (non-hormonal IUD is not allowed) within the last 3 months prior to screening must be willing not to change their method of contraception during the trial.OR Not using any hormonal method of contraception must be willing not to start any other method of contraception during the trial. They must use condoms after the period in which no sexual activity is allowed, i.e., following the primary evaluation timepoint\n6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n7. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives\n8. Willing to be asked questions about reproductive\u002Fsexual activity and use of vaginal products.\n9. Willing to provide and self-collect cervicovaginal secretions and vaginal swab samples at the clinic\n10. Willing to undergo vaginal cleansing and treatment procedures, including selfadministration of IMP, where required, at home.\n11. Willing to abstain from vaginal intercourse, following the first FB301 treatment until the primary evaluation timepoint\n12. Willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the Investigator following the first FB301 treatment until the primary evaluation timepoint\n13. Willing and able to comply with trial procedures and attending scheduled visits.\n14. No changes in medical conditions or prior\u002Fconcomitant therapy also regarding adherence to sexual behavior and contraceptive\u002Fbarrier requirements.\n\nExclusion Criteria:\n\n1. Known immunodeficiency conditions, including drug induced.\n2. Contraindication to metronidazole or chlorhexidine.\n3. Any known condition requiring regular use of antibiotics, which would suggest the likely requirement for antibiotic treatment during the trial.\n4. Any social, medical, or psychiatric condition that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial requirements or might interfere with the objectives of the trial.\n5. History of drug or alcohol abuse that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial or would complicate interpretation of data from participation.\n6. History of gynecological cancers, gynecological conditions, or surgical gynecological medical history which, in the opinion of the Investigator, precludes participation.\n7. Abnormal finding on the physical examination or gynecological examination or any other condition which, in the opinion of the Investigator, precludes participation.\n8. Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or active Herpes simplex \\[including PCR test positive\\]).\n9. Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response.\n10. Participants taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks or 5 half-lives (whichever is longer) before the start of trial treatment (unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial).\n11. Receiving treatment involving investigational drugs. Any previous investigational drug must have been completed at least 30 days prior to screening in this trial.\n12. Systemic and\u002For vaginally applied antibiotic use within the last 30 days prior to screening.\n13. Participants who are currently receiving antibacterial therapy unrelated to BV.\n14. Clinical laboratory test results which are clinically unacceptable at screening. Any clinically significant abnormal urinalysis should be repeated. If then confirmed abnormal and clinically significant, participant should be excluded. Any clinically significant out of range chemistry or hematology values should exclude the participant.\n15. Positive serum HBsAg (other than vaccination related), HCV and HIV antibody tests at screening.\n16. Positive test for Treponema pallidum (syphilis).\n17. Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).\n18. Aural body temperature of \\\u003C 35.5 or \\> 37.6°C at screening\n19. Pregnant, breastfeeding, has been pregnant within the last 2 months, or wishes to become pregnant within the next 6 months. Egg donation during the trial is not permitted.\n20. Use of a copper IUD (intrauterine device) within 12 weeks of screening. (Hormonal IUDs are permitted.)\n21. Use of probiotics, prebiotics or symbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods)\n22. Donation of more than 100 mL whole blood or plasma within 4 weeks before start of treatment or more than 500 mL of whole blood 3 months before start of treatment or intended blood donation during the trial.\n23. History of alcohol or substance dependency.\n24. Employee of the Sponsor, the CRS Group, or other CRO involved in the clinical trial.\n25. Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.\n\n    \\-",{"count":56,"type":22},120,[25],"The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an oral antibiotic (metronidazole), or both.\n\nThe main question it aims to answer is:\n\nDoes treatment with FB301, with or without pre-treatment using a vaginal antiseptic (chlorhexidine) or an oral antibiotic (metronidazole), change the balance of vaginal bacteria, measured by the proportion of two key bacteria (Lactobacillus crispatus and Lactobacillus jensenii), between the start of treatment and follow-up visits over the next 10 weeks?\n\nResearchers will compare participants randomly assigned to 4 different groups:\n\n* Group 1 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n* Group 2 will receive FB301for 15 days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n* Group 3 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive FB301 for an additional 15-days following a vaginal cleanse with chlorhexidine (antiseptic solution) on the first day only.\n* Group 4 will receive just FB301for 15 days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days.\n\nParticipants will:\n\n* Attend the study centre for up to 6 visits\n* Provide vaginal swab samples at up to 6 visits\n* Provide vaginal secretion samples using a menstrual disc at up to 4 visits\n* Have blood samples taken at up to 6 visits\n* Receive the study treatments for the randomly assigned group over two consecutive menstrual cycles.",[31],"2026-03-18",{"date":62,"type":40},"2026-03-20",{"date":64,"type":22},"2026-03-16",{"date":66,"type":22},"2027-04-21",{"name":68,"class":47},"Freya Biosciences ApS",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":69},"100571871","evaluation-of-the-medical-device-vagitab---t-as-adjuvant-therapy-in-patients-with-bacterial-vaginosis-100571871","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","65 Years",{"count":80,"type":22},30,[82],"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.",[31,85],"Recurrent Bacterial Vaginosis",[30,85,87,88],"Vaginal microflora","Lactobacillus","RECRUITING","2025-05-21",{"date":92,"type":40},"2025-05-28",{"date":94,"type":40},"2025-03-31",{"date":96,"type":22},"2025-09-30",{"name":98,"class":47},"S.I.I.T. Srl",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":69},"100566761","probiotic-efficacy-in-postmenopausal-women-with-bacterial-vaginosis-100566761","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,{"count":108,"type":22},12,[82],"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.",[31,112],"Menopause",[114],"NO","2024-10-24",{"date":117,"type":40},"2024-10-28",{"date":119,"type":40},"2024-06-26",{"date":121,"type":22},"2024-12-31",{"name":123,"class":124},"Hasanuddin University","OTHER"]