[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginosis-bacterial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginosis-bacterial":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639817","large-algorithm-setting-and-validation-study-100639817",false,"NCT07607470","Large Algorithm Setting and Validation Study","A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing","LAVA","Inclusion Criteria:\n\nBiologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis:\n\n* Abnormal vaginal discharge\n* Vaginal or vulvar itching, burning, or irritation\n* Painful or uncomfortable intercourse\n* Vaginal odor\n* Painful or frequent urination\n\nExclusion Criteria:\n\n* Participants who do not meet the above-described inclusion criteria will be excluded from the study.\n* Previously enrolled in this study\n* Contraindication to vaginal swab sampling","FEMALE","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.\n\nThe Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.",[25,26,27,28,29,30,31,32,33,34,35,36,37],"Bacterial Infections","Bacterial Infections and Mycoses","Infections","Vaginitis","Vaginal Diseases","Genital Diseases, Female","Female Urogenital Diseases","Urogenital Disease","Candidiasis","Mycoses","Vulvovaginitis","Vulvar Diseases","Vaginosis, Bacterial","NOT_YET_RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-26","ACTUAL",{"date":39,"type":21},{"date":45,"type":21},"2027-01",{"name":47,"class":48},"Nanopath, Inc","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"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":60,"type":21},160,"INTERVENTIONAL",[63,64],"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.",[37,67,68],"Bacterial Vaginosis","Bacterial Vaginosis (BV)",[70,71,72,67],"Recurrence","Microbiome","Metronidazole","2026-04-09",{"date":75,"type":42},"2026-04-14",{"date":77,"type":21},"2026-04-01",{"date":79,"type":21},"2027-10-01",{"name":81,"class":48},"Kaneka Americas Holding Inc.",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":17,"minAge":18,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":94,"conditions":95,"keywords":102,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":49},"100608318","impact-of-internal-menstrual-protections-on-immunity-and-vaginal-microbiota-100608318","NCT07199998","Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota","Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota","CUPS2","Inclusion Criteria:\n\n* Willingness to comply with all study procedures and availability for the duration of the study.\n* Female, aged 18 to 49 years.\n* In general good health, as determined by medical history.\n* Covered by the national health insurance system.\n* Willing to sign a written informed consent form.\n* Has already experienced menstruation prior to the start of the study.\n* No vaginal sexual intercourse within 72 hours before the study visit.\n* Has had at least 6 menstrual periods in the past 12 months.\n\nExclusion Criteria:\n\n* HIV infection.\n* Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.\n* History of hormonal disorders or menstrual cycle irregularities.\n* Metrorrhagia.\n* Pregnancy or breastfeeding.\n* Family members or close relatives of the clinical or scientific team.\n* Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.\n* Participation in an ongoing clinical trial.\n* Receiving or having received antibiotic treatment within the 4 weeks prior to the study.\n* Refusal to be informed in case of detected abnormalities.\n* Indistinct use of both tampons and menstrual cups.\n* Never having had vaginal penetrative intercourse.",true,"49 Years",{"count":93,"type":21},300,"The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.\n\nThis study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.",[96,37,97,32,98,99,100,101],"Sexual Transmitted Disease","Mycosis","HPV","Dysbiosis","Toxic Shock Syndrome","Menstrual Cup",[103,99,104,105,106,107,108],"Menstrual cup","Menstrual health","Menstrual protection","Menstrual pad","Tampon","Immunity","RECRUITING","2026-04-08",{"date":73,"type":42},{"date":113,"type":42},"2026-04-07",{"date":115,"type":21},"2027-03",{"name":117,"class":118},"Centre National de la Recherche Scientifique, France","OTHER"]