[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357008":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":66,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":12,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"vaginally delivered","NO_INTERVENTION","A non-randomized reference group of vaginally delivered infants.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"CS intervention","ACTIVE_COMPARATOR","A piece of gauze soaked with saline (0.9%) will be placed in the birth canal 2 hours before the CS by the study midwife, using sterile glows. Before the CS procedure begins, the gauze will be removed from the vagina and then immediately \"contaminated\" by a swab carrying maternal fecal microbiota. The swab is contaminated by introducing it 3 cm into the anal canal and by rotating it for 10-20 s.\n\nImmediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.",[18],"Other: Maternal microbiota",{"label":20,"type":21,"description":22,"interventionNames":23},"CS placebo","PLACEBO_COMPARATOR","See above - the gauze will be exchanged to a clean gauze (soaked with saline). Immediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.",[18],[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"Maternal microbiota","See arm descriptions",[14,20],[30],{"name":31,"affiliation":32,"role":33},"Susanne Nylén, PhD","Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":12,"email":39},"Lars G Engstrand, MD","CONTACT","+46706780318","lars.engstrand@ki.se",{"name":41,"role":37,"phone":42,"phoneExt":12,"email":43},"Marica C Hamsten, MSc","+46675555872","marica.hamsten@ki.se",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Stockholm","Stockholm County","171 65","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],18.06871,59.32938,{"lat":56,"lon":55},[59],{"name":41,"role":37,"phone":60,"phoneExt":12,"email":61},"+46765555872","marica.hamsten@k.se",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Lars Engstrand","professor, MD",[67,69,72,74,76],{"name":68,"class":6},"Uppsala University",{"name":70,"class":71},"Linkoeping University","OTHER_GOV",{"name":73,"class":6},"Umeå University",{"name":75,"class":6},"Örebro University, Sweden",{"name":77,"class":6},"Jonkoping University","100357008","restoration-of-microbiota-in-neonates-100357008",false,"NCT03928431","Restoration of Microbiota in Neonates","Restoration of Microbiota in Neonates - a Randomized Controlled Trial","RoMaNs","Inclusion Criteria:\n\n* Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand Swedish to the extent that they can consent in Swedish. An additional inclusion criterion for mothers in the CS groups is vaginal pH ≤ 4 at the time of birth.\n\nExclusion Criteria:\n\n* Infants of mothers with pre-eclampsia or complicated pregnancies, mothers \\\u003C18 years or \\>40 years of age, genital herpes simplex, genital warts, HIV, Hepatitis B or complications during delivery, infants delivered prior to 37 weeks of gestation. Additional exclusion criteria for mothers in the CS group: Mothers positive to Group B Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH \\> 4 at the time of birth. Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter or Yersinia.","ALL","5 Minutes","15 Minutes",{"count":90,"type":91},300,"ESTIMATED","INTERVENTIONAL",[94],"NA","The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood",[97,98,99],"Atopic Dermatitis","Atopic Asthma","Immunologic Activity Alteration",[101,102,103,104,105],"microbiota","cesarean section","vaginal delivery","allergy","immunological programming","2025-06-26",{"date":108,"type":109},"2025-07-01","ACTUAL",{"date":111,"type":109},"2019-01-01",{"date":113,"type":91},"2028-12-31",{"name":5,"class":6},1]