[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537832":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":41,"responsibleParty":53,"collaborators":56,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":18,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal microbiota transplant from biobank","EXPERIMENTAL","The newborns receive fecal microbiota transplant from their own mother (230 newborns).",[13],"Dietary Supplement: Donor-derived fecal microbiota transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Controls","NO_INTERVENTION","230 mothers and infants are recruited in no intervention group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Donor-derived fecal microbiota transplantation","A fecal microbiota transplantation prepared from stool donated by a healthy female donor from the study microbiota bank is administered orally to the newborn within 6 hours after birth following elective cesarean delivery.",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Terhi Ruuska-Loewald, Professor","Oulu Univeristy Hospital","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":32},"Marika Paalanne, MD, PhD","STUDY_DIRECTOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","+358505794646","marika.paalanne@oulu.fi",{"name":27,"role":35,"phone":39,"phoneExt":18,"email":40},"+358505794420","terhi.ruuska-loewald@oulu.fi",[42],{"facility":5,"status":43,"city":44,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":18},"RECRUITING","Oulu","Finland","FI",{"type":48,"coordinates":49},"Point",[50,51],25.46816,65.01236,{"lat":51,"lon":50},{"type":29,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marika Paalanne","MD, PhD, Associate Professor",[57,59,61,64,66,68],{"name":58,"class":6},"University of Oulu",{"name":60,"class":6},"University of Turku",{"name":62,"class":63},"Turku University Hospital","OTHER_GOV",{"name":65,"class":6},"University of Helsinki",{"name":67,"class":6},"Academy of Finland",{"name":69,"class":70},"Biocenter Oulu","UNKNOWN","100537832","health-outcomes-in-c-section-infants-with-fecal-microbiota-transplantation-100537832",false,"NCT06282952","Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation","Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)","SISU-FMT","Inclusion Criteria:\n\nPregnant women aged 18 to 49 years Scheduled for elective cesarean delivery at term (≥37 completed weeks of gestation) Willing and able to provide written informed consent Infant eligible for study participation following birth\n\nExclusion Criteria (Mother):\n\nAge \\\u003C18 years or \\>49 years Multiple pregnancy Regular use of immunosuppressive biological medication Diagnosed immunodeficiency in the mother Diagnosed immunodeficiency in a first-degree relative of the unborn child Known or suspected major congenital structural anomaly in the fetus Known or suspected fetal immunodeficiency Previous participation in the SISU-FMT study\n\nExclusion Criteria (Infant):\n\nPreterm birth (\\\u003C37 completed weeks of gestation) Birth weight \\\u003C2500 g Admission to a neonatal intensive care unit prior to the intervention Requirement for respiratory support prior to the intervention Requirement for systemic antibiotic treatment prior to the intervention","ALL","0 Hours","6 Hours",{"count":83,"type":84},460,"ESTIMATED","INTERVENTIONAL",[87],"NA","This single-center randomized controlled trial evaluates whether donor-derived fecal microbiota transplantation (FMT) administered within 6 hours after birth can improve gut microbiota development and reduce the risk of immune-mediated and metabolic diseases in infants born by elective cesarean delivery. Newborns are randomized 1:1 to receive either donor-derived FMT or standard postnatal care. Participants are followed through 36 months of age with stool samples, questionnaires, growth assessments, and health data collection, with registry-based follow-up continuing until 10 years of age.",[90,91,92],"Fecal Microbiota Transplantation","Cesarean Section","Overweight and Obesity",[90,91,92],"2026-07-17",{"date":96,"type":97},"2026-07-21","ACTUAL",{"date":99,"type":97},"2026-03-31",{"date":101,"type":84},"2036-12-31",{"name":5,"class":6},1]