[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565746":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":82,"overallOfficials":95,"centralContacts":99,"locations":108,"responsibleParty":170,"collaborators":173,"id":181,"slug":182,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":190,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":45,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":111,"whyStopped":45,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Swiss Tropical & Public Health Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Log-ratio of Dialister to Lactobacillus crispatus relative abundances in vaginal swabs (continuous variable)","The abundances of each bacterial taxa are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.","Monthly, after menstruation ends, through study completion, an average of 6 months.",[14,16,18,21,24,27,31,34,37,40,42],{"measure":15,"description":11,"timeFrame":12},"Log-ratio of Bifidobacterium vaginalis to Lactobacillus relative abundances in vaginal swabs (continuous variable)",{"measure":17,"description":11,"timeFrame":12},"Log-ratio of Prevotella to Lactobacillus relative abundances in vaginal swabs (continuous variable)",{"measure":19,"description":20,"timeFrame":12},"Dominant taxon in vaginal swabs (categorical variable)","The dominant taxon in a vaginal swab is defined as the most abundant taxon found with a relative abundance of at least 30% of the total bacterial DNA sequences found in the sample.",{"measure":22,"description":23,"timeFrame":12},"Community state type in vaginal swabs (categorical variable)","The community state type in a vaginal swab is defined using the VALENCIA algorithm as described in this article: France, M.T., Ma, B., Gajer, P. et al. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome 8, 166 (2020). https:\u002F\u002Fdoi.org\u002F10.1186\u002Fs40168-020-00934-6",{"measure":25,"description":26,"timeFrame":12},"Total bacterial load in vaginal swabs (continuous variable)","Indirectly estimated with qPCR of the 16S rRNA gene",{"measure":28,"description":29,"timeFrame":30},"Self-reported vaginal complaints (discrete variable)","Self-reported through follow up surveys along the six-month trial","Monthly, from enrollment until study completion, an average of 6 months.",{"measure":32,"description":33,"timeFrame":12},"Vaginal pH (ordinal variable)","Measured with a vaginal swab and a fixed indicator (3.6 - 6.1), just after menstruation ends.",{"measure":35,"description":36,"timeFrame":12},"Alpha diversity (continuous variable)","Alpha diversity indices (e.g., Shannon, Simpson) are estimated for each vaginal swab sample to quantify microbial richness and evenness.",{"measure":38,"description":39,"timeFrame":12},"Log-ratio of Gardnerella module to L. crispatus module relative abundances (continuous variable)","The abundances of each bacterial module are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.",{"measure":41,"description":39,"timeFrame":12},"Log-ratio of Prevotella module to L. crispatus module relative abundances (continuous variable)",{"measure":43,"description":44,"timeFrame":12},"molBV score (discrete variable)","The molBV score in a vaginal swab is defined and derived as described in this article: Usyk, M., Schlecht, N.F., Pickering, S. et al. molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history. Nat Commun 13, 233 (2022). https:\u002F\u002Fdoi.org\u002F10.1038\u002Fs41467-021-27628-3.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","CROSSOVER","A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and Switzerland). Each crossover period consists of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of 6 exposure sequences (different order of products per sequence); in each sequence, participants will adopt each menstrual product for 2 menstrual cycles. Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle. Given the crossover design of the study, there is not a dedicated control group. No wash-out period is included because participants can not stop the use of menstrual products to manage their menstruation.","BASIC_SCIENCE",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","In three countries, the investigators will follow a randomized crossover design to study the effects of menstrual products on the vaginal microbiome composition and diversity. Eligible participants who are willing to adopt pads, tampons and menstrual cups to manage their menstruation, and for which baseline composition of their vaginal microbiomes is determined through DNA sequencing of the 16s rRNA gene will enter a three-period crossover trial. Each period of the trial will consist of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of six different exposure sequences of menstrual products, as follows:\n\ni) Tampon, Cup, Pad ii) Tampon, Pad, Cup iii) Cup, Tampon, Pad iv) Cup, Pad, Tampon v) Pad, Tampon, Cup vi) Pad, Cup, Tampon\n\nIn group \"i)\", participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by the adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period). In groups ii) to vi) following the same design but in different sequences. Self-sampling kits will be provided during six consecutive menstrual cycles, a few days before the start of menses. Each kit will contain swabs for three self-sampling points during the menstrual cycle and the corresponding menstrual products.",[55,62,66,70,74,78],{"label":56,"type":6,"description":57,"interventionNames":58},"TamponCupPad","Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period).",[59,60,61],"Other: Menstrual Pads","Other: Menstrual Cups","Other: Tampons",{"label":63,"type":6,"description":64,"interventionNames":65},"TamponPadCup","Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of pads during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period).",[59,60,61],{"label":67,"type":6,"description":68,"interventionNames":69},"CupTamponPad","Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period).",[59,60,61],{"label":71,"type":6,"description":72,"interventionNames":73},"CupPadTampon","Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual pads during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period).",[59,60,61],{"label":75,"type":6,"description":76,"interventionNames":77},"PadTamponCup","Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period).",[59,60,61],{"label":79,"type":6,"description":80,"interventionNames":81},"PadCupTampon","Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual cups during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period).",[59,60,61],[83,87,91],{"type":6,"name":84,"description":85,"armGroupLabels":86,"otherNames":45},"Menstrual Pads","Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.",[71,67,79,75,56,63],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":45},"Menstrual Cups","Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.",[71,67,79,75,56,63],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":45},"Tampons","Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.",[71,67,79,75,56,63],[96],{"name":97,"affiliation":5,"role":98},"Sonja Merten, PhD","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":45,"email":104},"Sonja Merten, MD MPH PhD","CONTACT","0041-61-284-8387","sonja.merten@swisstph.ch",{"name":106,"role":102,"phone":103,"phoneExt":45,"email":107},"Monica Ticlla, PhD","monicaroxana.ticllaccenhua@swisstph.ch",[109,131,154],{"facility":110,"status":111,"city":112,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Centre de Recherche sur les Maladies Emergentes et Re-Emergentes","RECRUITING","Yaoundé","3","Cameroon","CM",{"type":117,"coordinates":118},"Point",[119,120],11.51667,3.86667,{"lat":120,"lon":119},[123,127],{"name":124,"role":102,"phone":125,"phoneExt":45,"email":126},"Esemu Livo, PhD","+237 674 632 078","esemu_livo@yahoo.com",{"name":128,"role":102,"phone":129,"phoneExt":45,"email":130},"Marie Josiane Kenfack, PhD(c)","+237676783165","kenfackjosiane@yahoo.fr",{"facility":132,"status":111,"city":133,"state":133,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Universidad Nacional de la Amazonia Peruana","Iquitos","16007","Peru","PE",{"type":117,"coordinates":138},[139,140],-73.2529,-3.74814,{"lat":140,"lon":139},[143,147,151],{"name":144,"role":102,"phone":145,"phoneExt":45,"email":146},"Viviana Pinedo, PhD","+51 955 850 853","viviana.pinedo@unapiquitos.edu.pe",{"name":148,"role":102,"phone":149,"phoneExt":45,"email":150},"Sandra Condori, PhD","+32 488 15 54 52","sandra.condori@uantwerpen.be",{"name":152,"role":153,"phone":45,"phoneExt":45,"email":45},"Katty Arista, M.Sc","SUB_INVESTIGATOR",{"facility":155,"status":111,"city":156,"state":156,"zip":157,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Swiss Tropical and Public Health Institute","Allschwil","4123","Switzerland","CH",{"type":117,"coordinates":161},[162,163],7.53599,47.55074,{"lat":163,"lon":162},[166,168],{"name":101,"role":102,"phone":167,"phoneExt":45,"email":104},"+41 79 640 17 27",{"name":106,"role":102,"phone":45,"phoneExt":45,"email":169},"monicaroxana.ticllaccenhua@unibas.ch",{"type":98,"investigatorFullName":171,"investigatorTitle":172,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Sonja Merten","Head of Unit Society, Gender and Health",[174,176,178,179],{"name":132,"class":175},"UNKNOWN",{"name":177,"class":6},"Universidad Peruana Cayetano Heredia",{"name":110,"class":175},{"name":180,"class":6},"Universiteit Antwerpen","100565746","improving-menstrual-and-vaginal-health-for-all-100565746",false,"NCT06646185","Improving Menstrual and VAginal Health for All","IMVAHA: Improving Menstrual and VAginal Health for All","IMVAHA","Inclusion Criteria:\n\n* able to provide informed consent;\n* aged 18-35;\n* residing in the recruitment region and expecting to reside in the same region for at least six months following recruitment (Yaoundé\u002F Gounougou, Cameroon; Loreto\u002FLima\u002FMaynas provinces, Peru; or Basel-Landschaft and Basel-Stadt cantons, Switzerland);\n* are native speakers or are able to read and understand one of the following languages in each respective country (German, French, Italian, English or Spanish in Switzerland; French or English in Cameroon; Spanish in Peru);\n* had menstrual cycles of 21-35 days for at least the last 4 months;\n* had menses which lasted at least 3 days for at least the last 4 months.\n\nExclusion criteria:\n\n* experienced a menstrual abnormality with any of the menstrual cycles in the last 4 months (such as oligomenorrhea or amenorrhea, or bleed more than 7 days a month);\n* are pregnant or actively trying to become pregnant;\n* are breastfeeding;\n* used antibiotics and\u002For vaginal antifungals in the last 30 days prior to recruitment;\n* had a vaginal birth in the last 6 months;\n* vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the last 6 months;\n* history of Toxic Shock Syndrome ;\n* positive to detection of the toxic shock syndrome toxin-1 gen (tst) using Polymerase Chain Reaction (PCR);\n* Intrauterine device in situ;\n* under medication (treatment against infectious or chronic disease) at the time of recruitment or during the 3 weeks prior to recruitment;\n* clinical symptoms of vaginal infection;\n* smoker.",true,"FEMALE","18 Years","35 Years",{"count":194,"type":195},100,"ESTIMATED","INTERVENTIONAL",[198],"NA","A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and Switzerland). Each crossover period consists of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of 6 exposure sequences (different order of products per sequence); in each sequence, participants will adopt each menstrual product for 2 menstrual cycles. Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle. Given the crossover design of the study, there is not a dedicated control group.",[201],"Effects of Menstrual Products on the Vaginal Microbiome",[203,204,205,206],"vaginal microbiome","menstruation","crossover study","menstrual products","2026-04-20",{"date":209,"type":210},"2026-04-23","ACTUAL",{"date":212,"type":210},"2026-04-15",{"date":214,"type":195},"2026-12-31",{"name":5,"class":6},3]