[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-microbiome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-microbiome":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,77,103,131,161],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100565506","the-influence-of-the-vaginal-microbiome-on-clinical-pregnancy-in-patients-undergoing-a-euploid-embryo-transfer-100565506",false,"NCT06643065","The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer","The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: A Prospective Blinded Multicentre Cohort Study","Inclusion Criteria:\n\n* ART patients undergoing the transfer of a euploid embryo\n\nExclusion Criteria:\n\n* Patients with a body mass index (BMI) ≥35\n\n  * Patients with uncorrected uterine malformations\n  * Patients with a unicornuate uterus\n  * Patients with a bicornuate uterus\n  * Patients with any type of submucosal myoma\n  * Patients with an intramural myoma if ≥4 cm\n  * Patients with severe adenomyosis (\\>50% of the uterine corpus affected as defined by the MUSA criteria \\[19\\])\n  * Patients undergoing transfer of an embryo with a morphology score \\\u003C4BC (according to the Gardner \\& Schoolcraft scoring system \\[18\\])\n  * Patients undergoing transfer of a day-7 embryo\n  * Patients who took antibiotics in the month prior to the embryo transfer (excluding antibiotics given following oocyte retrieval)","FEMALE","18 Years","50 Years",{"count":20,"type":21},1573,"ESTIMATED","OBSERVATIONAL","Microorganisms such as bacteria live naturally on and in the bodies and are of great importance for our health. In the female body, almost 10% of all microorganisms live in the reproductive organs and especially in the vagina. Healthy bacteria in the vagina can defend against harmful bacteria and infections. However, it occasionally happens that the balance between healthy and harmful bacteria is disturbed, and it is believed that this could potentially harm pregnancy. However, there is not much evidence to prove a connection between an imbalance in bacteria and having an unsuccessful pregnancy.\n\nFor this reason, the goal of our study is to determine if women with certain vaginal bacteria are more likely to experience pregnancy failures. If the investigators find this to be true, patients undergoing fertility treatment might be recommended regular tests in the future. If an imbalance in bacteria is found, doctors could provide treatment to restore a healthy vaginal environment, potentially improving the chances of a successful pregnancy.",[25],"Vaginal Microbiome",[27,28],"Female reproductive tract microbiome,","Vaginal dysbiosis","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":33},"2024-07-17",{"date":37,"type":21},"2027-09-30",{"name":39,"class":40},"Fundación IVI","OTHER",10,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100513529","synbiotics-in-patients-at-risk-for-preterm-birth-100513529","NCT05966649","Synbiotics in Patients at RIsk fOr Preterm Birth","Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal","PRIORI","Inclusion Criteria:\n\n1. Signed written informed consent must be obtained before any study assessment is performed;\n2. 18 years of age or older;\n3. Singleton pregnancy;\n4. Pregnancy consultation between 8 and 10 weeks gestation.\n5. At least one of the following risk factors for spontaneous preterm birth:\n\n   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency\n   * PPROM ≤36 weeks in previous pregnancy\n   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.\n\nExclusion Criteria:\n\n1. Patients who are already using pro-, pre- or synbiotics and not willing to stop\n2. Multiple pregnancy\n3. Need for primary (type 1) cerclage\n4. Inflammatory bowel disease\n5. Known congenital uterine anomaly\n6. History of LLETZ conization",true,{"count":52,"type":21},402,"INTERVENTIONAL",[55],"NA","Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.\n\nPrevious preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.\n\nInfections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).\n\nSynbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.",[58,59,60,61,25,62],"Preterm Spontaneous Labor With Preterm Delivery","Preterm Birth","Microbial Colonization","Microbiome Dysbiosis","Synbiotics",[64,65,66,62],"Preterm birth","Vaginal microbiome","Probiotics","2026-02-23",{"date":69,"type":33},"2026-02-27",{"date":71,"type":33},"2023-03-16",{"date":73,"type":21},"2029-06",{"name":75,"class":40},"Ziekenhuis Oost-Limburg",9,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100478488","uterine-microbiome-in-recurrent-pregnancy-loss-100478488","NCT05510622","Uterine Microbiome in Recurrent Pregnancy Loss","Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss","1. Recurrent pregnancy loss patients\n\n   Inclusion Criteria:\n   * 18-38 years old\n   * Having a regular menstrual cycle, from 25 to 35 days\n   * Having ≥ 2 recurrent pregnancy loss and\n   * Couples with normal karyotype results\n   * Having no condition causing pregnancy loss such as antiphospholipid syndrome, abnormal thyroid function.\n   * Agree to participate in the study\n\n   Exclusion Criteria:\n   * Irregular menstrual cycle\n   * Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)\n   * Using intrauterine device within the last 3 months\n   * Using antibiotic\u002Fvaginal pessary\u002Fcontraceptive pills within 2 weeks\n   * Having sexual intercourse within 48 hours\n2. Healthy control patients\n\nInclusion Criteria:\n\n* 18-38 years old\n* Having a regular menstrual cycle, from 25 to 35 days\n* No history of pregnancy loss\n* Having 1 or more live birth, with the youngest child ≥ 6 months old\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Irregular menstrual cycle\n* Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)\n* Using intrauterine device within the last 3 months\n* Using antibiotic\u002Fvaginal pessary\u002Fcontraceptive pills within 2 weeks\n* Having sexual intercourse within 48 hours","38 Years",{"count":86,"type":21},100,"The female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. Disturbances in this microbiome may be associated with adverse reproductive outcomes. The investigators hypothesize that the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss are different, compared with those in normal fertile women.",[89,25],"Recurrent Pregnancy Loss, Not Pregnant",[91,92],"Microbiome","Recurrent Pregnancy Loss","2025-09-22",{"date":95,"type":33},"2025-09-25",{"date":97,"type":33},"2022-12-12",{"date":99,"type":21},"2026-05",{"name":101,"class":40},"Mỹ Đức Hospital",2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":50,"sex":110,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":114,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100586188","the-maggie-project-exploring-the-origin-and-heredity-of-the-vaginal-microbiome-100586188","NCT06912126","The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome","Maggie","Inclusion Criteria of Central Participants:\n\n* Adults aged 18 and over at the time of enrollment;\n* Sex: Female;\n* Pre-menopausal;\n* Self-reported good health (including the absence of general infection) at the beginning of the study;\n* Living in Belgium;\n* Sufficient knowledge of the Dutch language;\n* Consent form signed;\n* Participating alongside her mother and at least one additional co-participant in the study.\n\nExclusion Criteria of Central Participants:\n\n* Current pregnancy or planned pregnancy at the beginning of the study;\n* Current diagnosis of cancer and\u002For immunosuppressive therapy in the 6 months before the study;\n* Clinically significant abnormalities of the reproductive organs or any other medical condition at the discretion of the principal investigator;\n* Use of oral\u002Fvaginal antibiotics\u002Fantifungals in the 2 months before the beginning of the study;\n* Use of oral\u002Fvaginal pre-, pro-, post- and\u002For synbiotics in the 2 weeks before the beginning of the study;\n* Vaginal showering during the study;\n* Participation in an intervention study.\n\nInclusion Criteria of Co-participants:\n\n* Closely related to or interacting with the central participant of the network at least during the last six months or more before the study, e.g. her mother, aunts, female cousins, sisters, daughters, housemates, partners or close friends;\n* Aged 18 or over at the time of enrollment; OR 10 or over if the co-participant's mother is also participating in the study;\n* Sex: Female; OR male aged 18 and over who is the partner or one of the partners (in case of polygamous relationships) of the central participant;\n* Self-reported good health (including the absence of general infection);\n* Sufficient knowledge of the Dutch language;\n* Consent form signed.\n\nExclusion Criteria of Co-participants:\n\n* Use of oral\u002Fvaginal antibiotics\u002Fantifungals in the 2 months before the study;\n* Parallel participation in an intervention study;\n* Vaginal showering during the study;\n* Clinically significant abnormalities of the reproductive organs or any other medical condition that, in the opinion of the principal investigator, warrants exclusion from the study.","ALL","10 Years",{"count":113,"type":21},500,"5 Years","The vaginal microbiome plays a crucial role in women's health and reproduction, impacting not only women but also their partners and children. However, its ecology and primary colonizers are not well understood. This study aims to explore the origin and heredity of the vaginal microbiome using a citizen science approach. The researchers will assemble a cohort of 100 networks, each with a central participant and 2 to 15 co-participants, totaling up to 500 participants. Participants will provide vaginal or penis swabs, complete questionnaires, and central participants will also donate stool samples. Girls under 18 may participate as co-participants if their mothers are enrolled, with first-void urine samples as an alternative method. Male partners can be included if they have intimate contact with central participants, but male family members and friends will not be part of the study. In the first phase, shared microbial strains along the gut-vagina axis and within the intimate microbiomes of participants from the same and different networks will be assessed. Transmission pathways will also be examined. Additionally, the metabolic environment in the vagina will be characterized. In the second phase, central participants will self-collect weekly vaginal swabs at three time points per year over five years. This phase will provide insights into the persistence and stability of the vaginal microbiome and the vaginal metabolic environment. If consent is given, genetic data from metagenomic sequencing will be analyzed to focus on variations related to the colonization, transmission, and persistence of microbial strains. This study will offer valuable insights into the origins, transmission, and long-term dynamics of the vaginal microbiome.",[25],[65,118,119,120],"Microbiome transmission","Longitudinal stability","Networks","2025-09-08",{"date":123,"type":33},"2025-09-09",{"date":125,"type":33},"2025-04-14",{"date":127,"type":21},"2032-01-31",{"name":129,"class":40},"University Hospital, Antwerp",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":53,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":130},"100601378","the-effect-cranberry-based-products-on-the-female-microbiome-100601378","NCT07109713","The Effect Cranberry-Based Products on the Female Microbiome","A Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome","Inclusion Criteria:\n\n* Pre-menopausal female,\n* 18 - 45 years of age (inclusive) at visit 1.\n* History of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior to visit 1. Participants that are using contraceptives (IUD, patch, or pills) must be on a stable dose, defined as no change in medication regimen, within 90 days of visit 1 (or within 6 months of visit 1 for copper IUD users) and no plans to change hormonal contraceptive use during the study.\n* BMI ≥18.5 to \\\u003C30.0 kg\u002Fm2 at visit 1.\n* Willing to adhere to all study procedures, including lifestyle considerations (see section 6.2), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.\n\nExclusion Criteria:\n\nWomen's health related criteria\n\n•Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.\n\nGeneral health related criteria\n\n* Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).\n* History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and\u002For affect study outcomes, in the judgment of the Investigator.\n* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit •Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 d of visit 1).\n* Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 days prior to testing.\n* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n* History of any major trauma or major surgical event within 2 months of visit 1.\n* Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.\n* Underwent an endoscopy or colonoscopy preparation within 3 months prior to visit 1.\n\nExclusionary products related criteria\n\n* Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \\>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).\n* Use of tobacco\u002Fnicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.\n* Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products, and willing to abstain from use throughout the study period (topical creams\u002Flotions are allowed). Occasional use (e.g., couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 d washout prior to visit 1 and the participant must be willing to refrain from use during the study.\n* Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days of visit 1. This exclusion criterion does not include hormonal contraceptives.\n* Exposed to any non-registered drug product within 30 days prior to visit 1.\n* Antibiotic use within 30 d of visit 1 and throughout the study period.\n* Steroid use within 30 d of visit 1 and throughout the study period.\n* Current habitual user (≥ 3 days\u002Fweek ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDs, acetaminophen, etc.).\n* Use of medications (over-the-counter or prescription) and\u002For dietary supplements, known to influence GI function, including but not limited to, pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and\u002For anti-spasmodic within 30 d of visit 1 and throughout the study period. Standard multivitamin and mineral supplements are allowed.\n* Willing to avoid consuming probiotics or fermented foods within 14 d of visit 1 and throughout the study period.\n* Willing to avoid consuming high-polyphenol foods and supplements \\[e.g., dark colored and polyphenol-rich fruits (berries, grapes, pomegranates, cherries, grapefruit, black currant, plum) and their processed food\u002Fjuice and related supplement products (e.g. grape seed extract, green tea extract); red wine; dark chocolate; cranberry extract supplements\\] throughout the study period.\n\nGeneral safety related criteria\n\n* Known sensitivity, intolerability, or allergy to any of the study products or their excipients.\n* Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk","45 Years",{"count":140,"type":21},60,[55],"The overall objective of this clinical trial is to compare the effects of a cranberry-based product to a placebo-control product on vaginal and GI microbiome outcomes and associated participant reported outcomes in generally healthy pre-menopausal women",[25,144,145],"Gut Microbiome","Gut Health",[147,148,149,150],"vaginal microbiome","gut microbiome","cranberry","polyphenols","2025-08-11",{"date":153,"type":33},"2025-08-14",{"date":155,"type":33},"2025-08-05",{"date":157,"type":21},"2025-12-20",{"name":159,"class":160},"Ocean Spray Cranberries, Inc.","INDUSTRY",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":50,"sex":16,"minAge":168,"maxAge":138,"enrollmentInfo":169,"targetDuration":4,"studyType":53,"phases":171,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":130},"100543449","phase-4-clinical-outcome-and-biomarkers-for-predicting-immunological-response-in-patients-treated-with-imiquimod-100543449","NCT06356012","Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod","Immunophenotyping, Microbiome, Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients with High-grade Cervical Intraepithelial Lesions Treated with Imiquimod","Inclusion Criteria:\n\n* Patients between 25 and 45 years of age (reproductive age);\n* High-risk HPV carriers;\n* Residents less than 300 km from the city of Barretos-São Paulo;\n* With a histological diagnosis of high-grade cervical squamous intraepithelial lesion (CIN 3), obtained through colposcopy-guided biopsy performed at the Barretos Cancer Hospital (HCB);\n* Acceptance of the Informed Consent Form.\n\nExclusion Criteria:\n\n* Suspicion of invasive squamous cell carcinoma or Adenocarcinoma (in situ or invasive) by colposcopy and\u002For cytology;\n* Pregnant or breastfeeding;\n* Immunodeficiency condition;\n* Previous treatment for high-grade cervical squamous intraepithelial lesion;\n* Who have been immunized for HPV;\n* Have used antibiotics in the last 30 days","25 Years",{"count":170,"type":21},96,[172],"PHASE4","The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients.",[175,25,176],"HSIL, High-Grade Squamous Intraepithelial Lesions","Biomarkers","2025-02-03",{"date":179,"type":33},"2025-02-05",{"date":181,"type":33},"2024-04-02",{"date":183,"type":21},"2028-12-31",{"name":185,"class":40},"Barretos Cancer Hospital"]