[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609268":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":17,"centralContacts":45,"locations":54,"responsibleParty":76,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":116,"overallStatus":57,"whyStopped":17,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of Helsinki","OTHER",[8,14,18,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","ACTIVE_COMPARATOR","The infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota.",[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":17},"Vaginal delivery","NO_INTERVENTION",null,{"label":19,"type":20,"description":21,"interventionNames":22},"Maternal bacteria set 1","EXPERIMENTAL","The infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother.",[13],{"label":24,"type":20,"description":25,"interventionNames":26},"Maternal bacteria set 2","The infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample.",[13],{"label":28,"type":6,"description":29,"interventionNames":30},"Maternal bacteria set 3","The infants will receive a mixture of bacterial strains isolated from other infants' and\u002For mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains.",[13],{"label":32,"type":33,"description":34,"interventionNames":35},"Placebo","PLACEBO_COMPARATOR","C-section born infants given a placebo treatment.",[36],"Other: Placebo",[38,42],{"type":39,"name":9,"description":40,"armGroupLabels":41,"otherNames":17},"DIETARY_SUPPLEMENT","Specific infant-adapted commercially available strains or strains isolated from the infant's mother.",[19,24,28,9],{"type":6,"name":32,"description":43,"armGroupLabels":44,"otherNames":17},"Infant formula without bacteria.",[32],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Katri E Korpela, PhD","CONTACT","+358504486369","katri.korpela@helsinki.fi",{"name":52,"role":48,"phone":17,"phoneExt":17,"email":53},"Marjo Metsäranta, MD, PhD","marjo.metsaranta@hus.fi",[55,70],{"facility":56,"status":57,"city":58,"state":17,"zip":17,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Helsinki University Hospital","RECRUITING","Helsinki","Finland","FI",{"type":62,"coordinates":63},"Point",[64,65],24.93545,60.16952,{"lat":65,"lon":64},[68],{"name":52,"role":48,"phone":69,"phoneExt":17,"email":53},"+358504272487",{"facility":5,"status":57,"city":58,"state":17,"zip":17,"country":59,"countryCode":60,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},{"type":62,"coordinates":72},[64,65],{"lat":65,"lon":64},[75],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Katri Korpela","Associate Professor",[81],{"name":82,"class":6},"Helsinki University Central Hospital","100609268","infant-microbiota-restoration-with-maternal-microbes-100609268",false,"NCT07212361","Infant Microbiota Restoration With Maternal Microbes","MaMi","Inclusion Criteria:\n\n* Healthy mother and healthy pregnancy\n* Singleton pregnancy,\n* Mothers who speak Finnish or Swedish\n* Mothers who are planning to breastfeed or give breastmilk by bottle to the infant\n* Infants who are expected to be healthy and who will not require BCG vaccination.\n\nExclusion Criteria:\n\n* Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland\n* Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant\n* Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery\n* Premature infants born before the pregnancy week 37\n* Infants, who are born by urgent cesarean section or emergency cesarean section\n* Infants, who receive antibiotics during the first week of life\n* Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.\n* Infants, who receive BCG-vaccine",true,"ALL","50 Years",{"count":94,"type":95},100,"ESTIMATED","INTERVENTIONAL",[98],"NA","The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:\n\nDo maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.\n\nParticipants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.",[101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"Infant, Newborn","Gut -Microbiota","Gut Dysbiosis","Cesarean Delivery Affecting Newborn","Cesarean Section","Vaginal Delivery","Gastrointestinal Microbiota","Microbiota, Cesarean Section, Probiotics, Dysbiosis","Feces","Delivery, Obstetric","Microbiota","Microbiology","Humans","Pregnancy","Neonate",[117,118,119,120,121,122],"Infant","newborn","cesarean section","neonate","restore","gut microbiota","2025-09-30",{"date":125,"type":126},"2025-10-08","ACTUAL",{"date":128,"type":126},"2025-07-17",{"date":130,"type":95},"2035-12-31",{"name":5,"class":6},2]