[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bacterial-vaginosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bacterial-vaginosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,54,83,112,143,164,187,216,241,262,284,307,332,359,382,410],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100054200","photobiomodulation-for-vaginal-dysfunctions-home-based-vs-outpatient-treatment-100054200",false,"NCT07697768","Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment","Therapeutic Response to Photobiomodulation in Home-Based and Outpatient Protocols for Vaginal Dysfunctions: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Women aged 18 to 75 years.\n* Clinical and\u002For laboratory-confirmed diagnosis of Genitourinary Syndrome of - Menopause (GSM), Bacterial Vaginosis (BV), or Vulvovaginal Candidiasis (VVC), according to established diagnostic criteria.\n* Ability to understand study procedures and provide written informed consent.\n* Willingness to comply with study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Use of a pacemaker or other implanted electronic medical device.\n* Active gynecological malignancy or suspicion of gynecological cancer.\n* Neurological and\u002For psychiatric disorders associated with cognitive impairment that may interfere with understanding study procedures.\n* Use of antibiotics, antifungal agents, corticosteroids, or vaginal creams within the previous 30 days in participants diagnosed with BV and\u002For VVC.\n* Suspected or confirmed vulvovaginal conditions other than GSM, BV, or VVC.\n* Any condition deemed by the investigators to compromise participant safety or interfere with study participation.","FEMALE","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Vaginal disorders, including vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and genitourinary syndrome of menopause (GSM), are highly prevalent conditions that significantly affect women's quality of life and sexual health. These disorders are associated with inflammatory changes, vaginal dysbiosis, and symptoms such as pruritus, abnormal vaginal discharge, dryness, and dyspareunia. In this context, photobiomodulation has emerged as a noninvasive therapeutic approach with anti-inflammatory and tissue-repair properties. This study is a randomized clinical trial designed to compare the therapeutic response to blue LED photobiomodulation (401 ± 5 nm) delivered through home-based and outpatient treatment protocols. A total of 150 women aged 18 to 75 years with a diagnosis of GSM, BV, or VVC will be enrolled and randomly assigned to one of two treatment groups. Clinical and laboratory assessments will be performed before and after treatment. Participants will also complete the Female Sexual Function Index (FSFI) and the 36-Item Short Form Health Survey (SF-36). Outcomes will include the evaluation of gynecological signs and symptoms, sexual function, quality of life, treatment adherence, and adverse events. The anticipated risks are minimal and primarily related to potential discomfort during gynecological examinations and possible embarrassment associated with discussing sensitive health information. The study is expected to demonstrate that photobiomodulation may improve clinical and functional outcomes, representing a safe, non-hormonal therapeutic alternative for the management of vaginal disorders.",[27,28,29],"Genitourinary Syndrome of Menopause (GSM)","Bacterial Vaginosis","Vulvovaginal Candidiasis (VVC)",[31,32,33,34,28,35,36,37,38,39,40],"Photobiomodulation","Blue LED","Vaginal Disorders","Vulvovaginal Candidiasis","Genitourinary Syndrome of Menopause","Sexual Function","Non-Hormonal Therapy","Randomized Clinical Trial","Home-Based Therapy","Outpatient Therapy","NOT_YET_RECRUITING","2026-07-09",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":21},"2026-07-30",{"date":49,"type":21},"2028-05-20",{"name":51,"class":52},"Patricia Lordelo","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443","NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","50 Years",{"count":62,"type":21},30,[64],"PHASE1","A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[67,68,69,70,71,28],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","2026-06-17",{"date":74,"type":45},"2026-06-23",{"date":76,"type":21},"2026-06-15",{"date":78,"type":21},"2027-05-05",{"name":80,"class":81},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":60,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100472609","the-lisa-lactoferrin-instead-of-antibioticsantifungals-feasibility-study-100472609","NCT05434104","The LISA (Lactoferrin InStead of Antibiotics\u002FAntifungals) Feasibility Study","Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic\u002FAntifungal Tablets for Women With Bacterial Vaginosis or Thrush?","LISA","Inclusion Criteria:\n\n* Aged 16-49 years\n\n  * Having periods (apart from women with a Mirena IUCD or polycystic ovary syndrome)\n  * Ability to consent\n  * Clinical diagnosis of BV or thrush confirmed on Gram stain\n  * Willing to be randomised to vaginal lactoferrin pessaries or oral antibiotics\u002Fantifungals\n  * Agrees to provide vaginal samples at home and post\u002Fdeliver them back to the research team.\n  * Agrees to avoid douching during the study (as this can flush out lactobacilli needed for a healthy microbiome).\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Currently has chlamydia, gonorrhoea or trichomonas (as treatment for these would affect the results).\n* Known allergy to metronidazole or azoles\n* Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)","16 Years",{"count":93,"type":21},114,[24],"Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush\u002Fcandida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and quality of life, and may need repeated courses of treatment. But some women prefer not to keep taking antibiotics which can have side effects and encourage the growth of resistant superbugs.\n\nLactoferrin is a prebiotic protein derived from cow's milk. Women also have naturally occurring lactoferrin in their vagina where it helps to prevent infections and encourage the growth of healthy bacteria. Recent research suggests lactoferrin may be an effective treatment for BV and thrush, but this needs to be confirmed.\n\nAim To see if it is feasible to conduct a future trial to prove whether lactoferrin vaginal pessaries are an acceptable, effective and cost-effective alternative to antibiotic tablets for women with BV or thrush.\n\nMethods The investigators will recruit a total of 57 women with BV and 57 with thrush from two sexual health clinics and a general practice. Women will be asked to provide self-taken vaginal samples with a cotton bud, and to complete a confidential sexual-health questionnaire. Then the women will be divided into two groups. One group will be given lactoferrin vaginal pessaries to use every night for 3-weeks. The other group will be given antibiotic\u002Fantifungal tablets. All women will be asked to provide repeat vaginal samples at home and text us about any symptoms to see if the treatment works, if the infection comes back and if they would like antibiotics. After 3 and 12-weeks all women will be invited back for a check-up.\n\nOutcome measures:\n\n* Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with 15-20 women\n* Recruitment and follow-up rates\n* Cost of lactoferrin treatment\n* The percentage of women who report their symptoms have resolved after a week\n* How quickly infections clear or recur - from analysis of samples\n\nPatient benefit:\n\nIf this study leads to a trial showing vaginal lactoferrin is an acceptable and effective alternative to antibiotics, this could help relieve symptoms, prevent antimicrobial resistance and save NHS costs.",[28,97],"Candida Vaginal",[99,100],"lactoferrin","prebiotic","RECRUITING","2026-05-27",{"date":104,"type":45},"2026-05-29",{"date":106,"type":45},"2026-04-16",{"date":108,"type":21},"2027-12",{"name":110,"class":52},"Guy's and St Thomas' NHS Foundation Trust",2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100633506","phase-2-study-to-evaluate-efficacy-and-safety-of-gyntima-balance-in-preventing-recurrences-of-bacterial-vaginosis-100633506","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.","45 Years",{"count":122,"type":21},160,[124,125],"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.",[128,28,129],"Vaginosis, Bacterial","Bacterial Vaginosis (BV)",[131,132,133,28],"Recurrence","Microbiome","Metronidazole","2026-04-09",{"date":136,"type":45},"2026-04-14",{"date":138,"type":21},"2026-04-01",{"date":140,"type":21},"2027-10-01",{"name":142,"class":81},"Kaneka Americas Holding Inc.",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":53},"100630130","phase-2-efficacy-and-safety-study-of-bpr-101-capsules-in-combination-with-metronidazole-in-bv-patients-100630130","NCT07483671","Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients","A Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of BPR-101 Capsules in Combination With Metronidazole for the Prevention of Recurrence of Bacterial Vaginosis (BV).","Inclusion Criteria:\n\n1. Females aged ≥18 years and ≤50 years, of childbearing age with a history of sexual activity;\n2. Clinically diagnosed with Bacterial Vaginosis (BV), this test requires meeting at least 3 of the following 4 Amsel criteria (with a positive clue cell test being a mandatory condition): positive clue cells; positive amine test; vaginal discharge pH \\> 4.5; and Vaginal discharge is homogeneous, thin, and grayish-white in appearance；\n3. Nugent score ≥ 7 points；\n4. Vaginal administration is acceptable, and the patient agrees to avoid using any other vaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) except as specified in the trial throughout the entire trial period；\n5. Researchers have assessed that the menstrual cycle is regular;\n6. Subjects must voluntarily sign a written informed consent form before the trial, understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol and complete the trial.\n\nExclusion Criteria:\n\n1. Currently suffering from pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention, among other acute infections of the genitourinary system;\n2. Presence of vulvovaginitis caused by other pathogens, which researchers considered to affect trial evaluation, such as aerobic vaginitis (AV), vulvovaginal candidiasis (VVC), and trichomoniasis；\n3. Currently, other vaginal or vulvar diseases are considered by researchers to affect the evaluation of the trial, such as human papillomavirus infection; or gynecological examinations showing condyloma acuminata or genital herpes；\n4. Unexplained abnormal vaginal bleeding within 6 months prior to screening or during the screening visit;\n5. Those who currently have uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis, and for whom researchers believe that intervention is necessary during the trial;\n6. Received local or systemic antifungal or antibiotic treatment or probiotic treatment within 2 weeks prior to screening; or vaginal douching or other vaginal treatments (such as Jieeryin, Jieyinkang, etc.) within 1 week prior to screening, and\u002For expected to receive the above treatments during the trial;\n7. Used systemic steroids (oral or injectable), disulfiram, lithium salts within 14 days prior to screening., and\u002For expected to receive such treatment during the trial;\n8. Currently using and\u002For expected to require cimetidine, warfarin (or other anticoagulation therapy) during the trial;\n9. Products containing alcohol or propylene glycol that are expected to be used within 3 days prior to screening and\u002For during the trial period;\n10. Hhistory of malignant tumors within 5 years prior to screening and deemed unsuitable for inclusion by the researchers, except for those with adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ;\n11. Hhistory of major gynecological surgery within 6 months prior to screening(deep wounds, long recovery time), or superficial gynecological surgery or common procedures within 60 days prior to screening，or whose screening visit is within 60 days of their last termination of pregnancy;\n12. History of or currently suffering from serious diseases of the cardiovascular, liver, kidney, lung, digestive tract, nervous and mental system, genitourinary system, endocrine system, etc., and are deemed unsuitable for inclusion by the researchers;\n13. Laboratory tests meeting any of the following criteria, and the investigator deems them unsuitable for inclusion: serum creatinine \\> 1.5 times the upper limit of normal (ULN); urea\u002Furea nitrogen \\> 1.5 ULN; alanine aminotransferase (ALT) \\> 2 ULN; aspartate aminotransferase (AST) \\> 2 ULN;\n14. Known hypersensitivity to any component of BPR-101 capsules or to other similar drugs (such as Live Lactobacillus Capsule for Vaginal Use ); or nitroimidazole, metronidazole, or any of the excipients；\n15. Women who are pregnant or breastfeeding, or whose pregnancy test results are positive, or who plan to become pregnant throughout the trial and within 3 months after the last dose; or who cannot accept the use of reliable contraception (absence of sexual intercourse or barrier contraception with condoms throughout the study period);\n16. Participated in other drug or device clinical trials within 1 month prior to screening and have used the investigational drug or device;\n17. The researchers believe that the subject has any other circumstances that would make them unsuitable to participate in the trial.",{"count":151,"type":21},80,[124],"This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.",[28],"2026-03-17",{"date":157,"type":45},"2026-03-19",{"date":159,"type":21},"2026-04-15",{"date":161,"type":21},"2027-01-24",{"name":163,"class":81},"Chengdu Syncor Pharmaceutical Co., Ltd.",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":170,"sex":16,"minAge":17,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":53},"100497174","early-phase-1-exploring-the-effects-of-an-intravaginal-lactic-acid-gel-on-the-vaginal-microbiome-100497174","NCT05753813","Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome","Inclusion Criteria:\n\n* Age 18-54\n* Female\n* Pre-menopausal\n* Can speak and read in English\n* Displays capacity for informed consent\n* Has had 2 or more documented and\u002For self-reported episodes of symptomatic BV or candida infection in the last year, requiring, over-the-counter or prescription treatment\n\nExclusion Criteria:\n\n* Pregnant or trying to become pregnant\n* Post-menopausal\n* Using NuvaRing device\n* A past medical history of kidney disease, recurrent UTI, and\u002For urinary tract abnormalities\n* Current UTI\n* Using Phexxi as a contraceptive during the collection period of the study",true,"54 Years",{"count":173,"type":21},22,[175],"EARLY_PHASE1","This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.",[28,34],"2026-02-18",{"date":180,"type":45},"2026-02-20",{"date":182,"type":45},"2023-12-15",{"date":184,"type":21},"2026-12-30",{"name":186,"class":52},"Queen's Medical Center",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":170,"sex":16,"minAge":17,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":53},"100616163","phase-1-a-first-in-human-safety-and-pharmacokinetic-trial-of-gensci142-administered-as-single-ascending-doses-in-healthy-chinese-women-100616163","NCT07302035","A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women","A Phase Ia Single-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Trial of GenSci142 Administered in Single Ascending Doses in Healthy Chinese Women","Inclusion Criteria:\n\n* Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF);\n* Sexually active and willing to undergo vaginal administration of the study product；participants must agree to avoid the use of other intravaginal products (e.g., contraception ointments, gels, foams, sponges, lubricants, irrigation solutions, tampons, etc.) throughout the trial;\n* During the screening period, there are no clinically significant abnormalities in medical history, vital signs, physical examination, gynecological examination, laboratory test (hematology, routine urinalysis, clinical chemistry, coagulation function, vaginal microbiome test) and 12-lead ECG, or any out-of-range laboratory values or other findings must be assessed by the investigator as not clinically significant;\n\nExclusion Criteria:\n\n* Those experiencing stinging or burning sensation, hemorrhage, pruritus, erythema, edema, or increased discharge due to previous or current use of vaginal preparations, or those with any factors that possibly have an impact on evaluation of administration site irritation, or those with other factors that may have an impact on vaginal administration, such as genital malformation;\n* Serious infections, chronic infections, opportunistic infections, etc. within 3 months prior to screening, and infections treated with systemic antimicrobial drugs (including but not limited to viruses, bacteria, fungi, and parasitic infections) within 4 weeks prior to randomization;\n* Surgical history: a. vaginal, pelvic or cervical surgery within 90 days prior to screening or planning to undergo surgery during the study; b. hysterectomy; c. other major surgery within 30 days prior to screening or planning to undergo other surgeries during the study;","55 Years",{"count":62,"type":21},[64],"This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.",[28],[200,201,202,203,204,205,206,207],"Bacterial Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Gardnerella spp.","Gardnerella vaginalis","GenSci142","2025-12-10",{"date":210,"type":45},"2025-12-24",{"date":212,"type":21},"2025-12",{"date":214,"type":21},"2026-12",{"name":80,"class":81},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":170,"sex":16,"minAge":224,"maxAge":18,"enrollmentInfo":225,"targetDuration":227,"studyType":228,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":53},"100196134","prospective-data-bank-creation-to-study-vaginal-conditions-100196134","NCT01829204","Prospective Data Bank Creation to Study Vaginal Conditions","A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach","CRIPB-13-002","Inclusion Criteria:\n\n* All patients willing to participate, and give informed consent, and\n* Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.\n* Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.\n* Pregnant women ages 21 to 75 years who are both asymptomatic and healthy\n* Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition\n\nExclusion Criteria:\n\n* Asymptomatic patients ages \\\u003C 21 or \\> 75, or symptomatic patients ages \\\u003C 21 or \\> 75 years.\n* Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks\n* Patients unable to follow the protocol or unwilling to participate","21 Years",{"count":226,"type":21},550,"12 Months","OBSERVATIONAL","The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.",[231,232,28,233],"Vulvodynia","Mycoses","Preterm Labor",{"date":235,"type":45},"2025-12-18",{"date":237,"type":4},"2013-04",{"date":108,"type":21},{"name":240,"class":52},"Texas Tech University Health Sciences Center",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":53},"100610992","clinical-study-of-a-vaginal-gel-for-the-treatment-and-prevention-of-vaginal-infections-100610992","NCT07234786","Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections","Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn FemiTotal for Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis.","Inclusion Criteria\n\n1. Age ≥ 18 years old.\n2. Women suffering from VVC or BV at the time of inclusion:\n3. For VVC: Subject with at least itching score \\> 2 and crumbly white discharge.\n4. For BV: Subject with at least 3 out of 4 Amsel criteria positive, with at least presence of clue cells (\\>20%).\n\n   Amsel criteria used for the study:\n   * Thin, white, yellow, homogeneous discharge,\n   * Clue cells on wet mount microscopy \\>20%,\n   * a vaginal fluid pH ≥4.5 when placing the discharge on litmus paper,\n   * Release fishy odor after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as \"whiff test\".\n5. Subject having given freely and expressly her informed consent.\n6. Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before inclusion visit and during the whole study.\n7. Subject cooperative and aware of the device's modalities of use and the necessity and duration of the follow-up visits so that perfect adhesion to the protocol can be expected\n\nExclusion Criteria:\n\n1. Pregnant or nursing woman or planning a pregnancy during the study.\n2. Subject suspected to be non-compliant according to the investigator's judgment.\n3. Subject enrolled in another clinical trial during the study period on the vaginal area.\n4. Subject having a known allergy or hypersensitivity to one of the components of the investigational device.\n5. Subject suffering from a sexually transmitted gynaecological infection, genital tract infection or aerobic vaginitis (including clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).\n6. Subject with current genital malignancies.\n7. Subject who had a chemotherapy treatment in the 6 months before inclusion.\n8. Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.\n9. Subject using treatment for vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.\n10. Subject using antibiotics for any reason in the 14 days before inclusion.\n11. Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.\n12. Subject with a pessary.\n13. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk",{"count":151,"type":21},[24],"The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered as cured 21 days after the beginning of treatment, the subjects will be followed-up until Month 4 after treatment initiation to check the re-occurrence of VVC and BV (prevention phase).The primary objective is to evaluate the effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal Candidiasis (VVC) itching, 21 days after treatment initiation.",[28,252],"Vaginal Candidiasis","2025-11-14",{"date":255,"type":45},"2025-11-18",{"date":257,"type":45},"2025-10-20",{"date":259,"type":21},"2027-03-31",{"name":261,"class":81},"Karo Pharma AB",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":170,"sex":16,"minAge":17,"maxAge":194,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":53},"100421740","phase-4-a-prospective-randomized-controlled-study-of-the-probiotics-as-adjuvant-treatment-for-bacterial-vaginosis-100421740","NCT04771728","A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis","Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital","Inclusion Criteria:\n\n1. Aged 18 to 55 years old, with history of sexual activity,\n2. Amsel criterion for diagnosing BV\n3. Sign informed consent\n\nExclusion Criteria:\n\n1. History of systemic organic diseases or psychiatric diseases\n2. Planning for or during pregnancy, lactation, menstruation\n3. within 5 days of onset of the disease, any antibiotics has been used\n4. Long-term use of contraceptives or immunosuppressant\n5. Anaphylactic constitution or allergic to known ingredients of research drugs\n6. No same fixed partner (RSP) before and after treatment",{"count":270,"type":21},140,[272],"PHASE4","The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis",[28],"2025-06-09",{"date":277,"type":45},"2025-06-12",{"date":279,"type":45},"2020-02-01",{"date":281,"type":21},"2026-12-01",{"name":283,"class":52},"Peking University Shenzhen Hospital",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100587825","clinical-protocol-cern-feasibility-study-100587825","NCT06933420","Clinical Protocol CERN Feasibility Study","Feasibility\u002FFirst in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis","Inclusion Criteria:\n\n* Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis\n\nExclusion Criteria:\n\n* Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.",{"count":292,"type":21},9,[24],"The goal of this clinical trial is to learn if the intravaginal Cern device works to treat bacterial vaginosis and fungal vaginitis in premenopausal women. It will also learn about the safety of the device. The main questions it aims to answer are: Does the device accomplish symptom resolution and negative diagnostic tests post-treatment? What medical problems do participants have when using the intravaginal device? Participants will use the investigational intravaginal device for 5 consecutive days, participate in teleconferences and weekly follow-ups, attend in-clinic visits, and maintain a study diary.",[28,296],"Fungal Vaginal Infections","2025-04-10",{"date":299,"type":45},"2025-04-18",{"date":301,"type":45},"2024-11-06",{"date":303,"type":21},"2025-05",{"name":305,"class":81},"Cern Corporation",3,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":111},"100551319","phase-4-optimization-of-bacterial-vaginosis-treatment-in-women-of-reproductive-age-100551319","NCT06458543","Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age","Efficacy of Bovhyaluronidase Azoximer on Biofilms Destruction in the Urogenital Tract of the Patients With Reccurent Bacterial Vaginosis.","Inclusion Criteria:\n\n* The written informed consent of the patient to participate in the study;\n* Age (18 - 45 years old);\n* The established diagnosis of Bacterial vaginosis;\n* Absence of pregnancy and lactation.\n\nExclusion Criteria:\n\n* Refusal of the patient from further participation in the study;\n* Lack of patient adherence to treatment;\n* The occurrence of conditions and diseases related to the list of contraindications to the use of the studied drug during the study.\n* The presence of Neisseria gonorrhoeae, Trichomonas vaginalis, confirmed by laboratory;\n* The presence of contraindications to the use of the studied drug according to the instructions for the drug.",{"count":315,"type":21},100,[272],"The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are:\n\n* Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium\n* use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis.\n* use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis.\n\nParticipants in the experimental and control group will be:\n\n* Amsel criteria assessment\n* Colpotest-PH (vaginal acidity)\n* aminotest with 10% KOH solution (\"fish odor\")\n* microscopic examination of vaginal discharge\n* Bacteriologic culture of vaginal discharge\n* Polymerase chain reaction of epithelial cell scrapings from the vagina\n* electron microscopy of vaginal epithelial cell scrapings\n\nParticipants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole.\n\nParticipants in the control group: Metronidazole.\n\nResearchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.",[28],[28,320,321,322],"biofilms","bovhyaluronidase azoximer","treatment","2025-04-07",{"date":325,"type":45},"2025-04-09",{"date":327,"type":45},"2024-06-01",{"date":329,"type":21},"2026-06-01",{"name":331,"class":52},"I.M. Sechenov First Moscow State Medical University",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":170,"sex":339,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":53},"100513303","the-genital-microbiome-of-male-partners-of-women-with-recurrent-bv-undergoing-vaginal-microbiome-transplantation-100513303","NCT05963711","The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation","The Penile Microbiome in Partners of Women with Recurrent BV and Its Response to Decolonization Protocol","Inclusion Criteria:\n\n* The subject has s female partner who participates in VMT study ( NCT04517487).\n* The subject is defined by the woman as her male regular partner.\n* Willing to use a condom as instructed by the protocol.\n* Willing to comply with decolonization protocol.\n\nExclusion Criteria:\n\n* A known skin disease involving the penile skin.\n* A known sensitivity to chlorhexidine gluconate\n* Any of the partners (female\u002Fmale) has more than one sexual partner.","MALE",{"count":315,"type":21},[24],"There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.\n\nAlthough BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.\n\nThis study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.",[28,344],"Microbial Colonization",[346,347,348,349],"Penile microbiome","Vaginal microbiome transplant","Male partners","Bacterial vaginosis","2025-03-15",{"date":352,"type":45},"2025-03-19",{"date":354,"type":45},"2022-10-17",{"date":356,"type":21},"2026-06",{"name":358,"class":52},"Hadassah Medical Organization",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":366,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":53},"100567203","a-study-to-evaluate-the-effects-of-a-prebiotic-and-probiotic-supplement-to-provide-relief-from-symptoms-associated-with-bacterial-vaginosis-and-yeast-infections-100567203","NCT06665126","A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.","A Triple-Group Randomized Controlled Trial to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.","Inclusion Criteria:\n\n* Women\n* Age 25+\n* Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.\n* Suffers from digestive issues, including bloating, gas, or other digestive discomfort.\n* Generally healthy - do not live with any uncontrolled chronic diseases.\n* Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.\n* If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.\n\nExclusion Criteria:\n\n* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders\n* Planning to undergo any procedure related to their vaginal health.\n* Started any new medications or supplements that target vaginal health in the past 3 months.\n* Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients\n* Women who are pregnant, breastfeeding, or attempting to conceive\n* Unwilling to follow the study protocol\n* Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.","25 Years",{"count":368,"type":21},120,[24],"This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.",[28,372],"Yeast Infection","2024-10-28",{"date":375,"type":45},"2024-10-30",{"date":377,"type":21},"2024-11-01",{"date":379,"type":21},"2025-05-30",{"name":381,"class":81},"Happy V",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":4},"100550739","phase-1-efficacy-safety-and-dose-response-of-a-live-biotherapeutic-product-in-women-with-acute-vaginal-infection-100550739","NCT06450990","Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection","Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study","ELINA","Inclusion Criteria:\n\n* Post-menarche woman aged 18 to 50 years old (inclusive),\n* With suspected Bacterial Vaginosis (BV) and\u002For Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection\n* No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,\n* Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,\n\nExclusion Criteria:\n\n* Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month\n* Current herpes simplex flare-up in the genital area,\n* Vulvar condyloma due to the human papilloma virus;\n* Vulvar dermatoses (e.g.: psoriasis or lichenification);\n* Clinical diagnosis of BV or VVC within 4 months;\n* Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;\n* Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;\n* Participant using any intravaginal product (local contraceptive \\[spermicide, hormonal ring\\], moisturizer, tampon, intimate hygiene product, etc.);\n* Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.\n* Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;\n* Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause;\n* With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;",{"count":391,"type":21},165,[64,124],"The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis",[28,34],[396,129,29,397,398,206,399,400],"Vaginal infection","Anaerobic bacteria","Prevotella","Candida albicans","Acute Vaginitis","2024-06-10",{"date":403,"type":45},"2024-06-12",{"date":405,"type":21},"2024-07-08",{"date":407,"type":21},"2026-02-26",{"name":409,"class":81},"NEXBIOME THERAPEUTICS",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":425,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":4},"100542919","phase-4-screen-and-treat-strategy-for-vaginal-flora-abnormalities-in-pregnant-women-at-high-risk-of-preterm-birth-100542919","NCT06349122","Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth","Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2)","AUTOP2","Inclusion Criteria:\n\n* Pregnant women over 18 years of age\n* Pregnant woman after 8 weeks and before 18 weeks of gestation (i.e. \\>=8 weeks and ≤ 18 weeks)\n* Woman who has understood the study process and objectives and agreed to sign an informed consent form;\n* With a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population) (A late miscarriage or late fetal loss mean foetal loss between 14 and 22 weeks of gestation)\n* Affiliated to a social security regimen or equivalent\n\nExclusion Criteria:\n\n* \\- Woman of legal age under legal protection;\n* Women deprived of their freedom for administrative or legal reasons;\n* Woman who has not signed a consent form\n* Nulliparous;\n* Ectopic pregnancy;\n* Non-evolutive pregnancy or IUFD\n* Multiple pregnancy\n* Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly.\n* Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study\n* Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients\n* Woman presenting uterine malformation ( unicornuate, bicornuate, full septate)\n* Woman with preterm birth history because of twin pregnancy\n* Woman having received anti-infective treatment in the week preceding inclusion",{"count":419,"type":21},1292,[272],"Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.\n\nThe main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.\n\nThe hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.",[28,423,424],"Vaginal Dysbiosis","Premature Delivery",[426],"screen and treat strategy","2024-03-29",{"date":429,"type":45},"2024-04-05",{"date":431,"type":21},"2024-08",{"date":433,"type":21},"2028-01",{"name":435,"class":52},"Assistance Publique Hopitaux De Marseille"]