[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513303":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":14,"responsibleParty":33,"collaborators":7,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":7,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":7,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":12},"chlorhexidine gluconate 4%","In case BV associated bacteria will be identified (using molecular sequencing) in male samples, decolonization attempt will be conducted, using a daily wash for 5 days with chlorhexidine gluconate 4%. Following decolonization attempt, male participants will undergo re- sampling, to assess for microbiome changes.\n\nIn case there is no change in microbial composition, partners will be instructed to repeat decolonization protocol, and apply a 2 cm diameter volume of 2% clindamycin cream topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days following repeated decolonization. Re-sampling will follow.",[13],"2% clindamycin cream",[15],{"facility":16,"status":17,"city":18,"state":7,"zip":7,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"Hadassah Medical Center","RECRUITING","Jerusalem","Israel","IL",{"type":22,"coordinates":23},"Point",[24,25],35.21633,31.76904,{"lat":25,"lon":24},[28],{"name":29,"role":30,"phone":31,"phoneExt":7,"email":32},"Ahinoam Lev Sagie, MD","CONTACT","+972-54-4327178","levsagie@netvision.net.il",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Ahinoam Lev-Sagie","Professor","100513303","the-genital-microbiome-of-male-partners-of-women-with-recurrent-bv-undergoing-vaginal-microbiome-transplantation-100513303",false,"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.",true,"MALE","18 Years",{"count":48,"type":49},100,"ESTIMATED","INTERVENTIONAL",[52],"NA","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.",[55,56],"Bacterial Vaginosis","Microbial Colonization",[58,59,60,61],"Penile microbiome","Vaginal microbiome transplant","Male partners","Bacterial vaginosis","2025-03-15",{"date":64,"type":65},"2025-03-19","ACTUAL",{"date":67,"type":65},"2022-10-17",{"date":69,"type":49},"2026-06",{"name":5,"class":6},1]