[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537832":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":38,"locations":46,"responsibleParty":58,"collaborators":61,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal microbiota transplant from biobank","EXPERIMENTAL","The newborns receive fecal microbiota transplant from their own mother (237 newborns).",[13],"Dietary Supplement: Microbiota transplant from mother",{"label":15,"type":16,"description":17,"interventionNames":18},"Fecal microbiota transplant from own mother","ACTIVE_COMPARATOR","Newborns receive fecal microbiota transplant from normal weight, healthy female donor from the Microbiome Biobank (60 newborns).",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Controls","NO_INTERVENTION","237 mothers and infants are recruited in no intervention group.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DIETARY_SUPPLEMENT","Microbiota transplant from mother","At delivery, the microbiota transplant is thawed and 0.5 mL representing 3.5 mg of the mother's or donors' fecal sample is dissolved in 5 mL of the mother's own milk or when not available pasteurized bank milk. The sample is given orally to newborn infants as soon as possible but not later than 6 h of delivery and not later than two hours after defrosting.",[9,15],[31,35],{"name":32,"affiliation":33,"role":34},"Terhi Ruuska-Loewald, Professor","Oulu Univeristy Hospital","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":37},"Marika Paalanne, MD, PhD","STUDY_DIRECTOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":23,"email":42},"CONTACT","+358505794646","marika.paalanne@oulu.fi",{"name":32,"role":40,"phone":44,"phoneExt":23,"email":45},"+358505794420","terhi.ruuska-loewald@oulu.fi",[47],{"facility":5,"status":48,"city":49,"state":23,"zip":23,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":23},"RECRUITING","Oulu","Finland","FI",{"type":53,"coordinates":54},"Point",[55,56],25.46816,65.01236,{"lat":56,"lon":55},{"type":34,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Marika Paalanne","MD, PhD, Associate Professor",[62,64,66,69,71,73],{"name":63,"class":6},"University of Oulu",{"name":65,"class":6},"University of Turku",{"name":67,"class":68},"Turku University Hospital","OTHER_GOV",{"name":70,"class":6},"University of Helsinki",{"name":72,"class":6},"Academy of Finland",{"name":74,"class":75},"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\n* Pregnant women age 18-49 years who are scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.\n\nExclusion Criteria:\n\n* Use of regular immunosuppressive biological medication; inflammatory bowel disease in the mother; immunodeficiency disorder of the mother or any first-degree family member of the unborn baby; known or suspected major fetal congenital abnormality; travel outside Europe, the United States, Canada, Japan, Australia, or New Zealand within the last three months; and antibiotic treatment within three months of delivery (excluding prophylactic cefuroxime - or an alternative in case of allergy - administered prior to the elective cesarean section).\n* Infant exclusion criteria are preterm birth (birth before 37 weeks of gestation), birth weight below 2500 g, admission to neonatal intensive care unit, need for respiratory support or antibiotic treatment of the newborn before discharge. In case of a suspected infection or newborn screening result for severe combined immunodeficiency (SCID) is out of the normal range, of the newborn the randomization code can be opened.","FEMALE","18 Years","49 Years",{"count":88,"type":89},534,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:\n\n* Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity.\n* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.",[95,96,97],"Fecal Microbiota Transplantation","Cesarean Section","Overweight and Obesity",[95,96,97],"2026-04-01",{"date":101,"type":102},"2026-04-07","ACTUAL",{"date":104,"type":102},"2026-03-31",{"date":106,"type":89},"2036-12-31",{"name":5,"class":6},1]