[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533594":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":18,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","10 infants born by CS to screening negative mothers receive an oral maternal fecal transplant (from their own mother) containing 0.35mg\u002Fkg of maternal fecal content at the age of 2-7 days of age.",[13],"Other: Fecal microbiota transplant",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","12 infants born by CS (8 to screening negative mothers and 4 to screening positive mothers in case of Blastocystis hominis or Dientamoeba fragilis).",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Comparison","Infants born vaginally to mothers with screening negative or mild pathogene findings (Blastocystis hominis or Dientamoeba fragilis)",[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":18},"Fecal microbiota transplant","0.1-0.3 ml liquid containing 3.5 mg\u002Fml of maternal fecal content, (0.35mg\u002Fkg)",[9],[28],{"name":29,"affiliation":30,"role":31},"Otto Helve, Docent","University of Helsinki","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Noora K Carpén, MD","CONTACT","+358 9 4711","noora.carpen@hus.fi",{"name":39,"role":35,"phone":36,"phoneExt":18,"email":40},"Samuli Rautava, Associate Professor","samuli.rautava@hus.fi",[42],{"facility":43,"status":18,"city":44,"state":45,"zip":18,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Helsinki University Hospital","Helsinki","Uusimaa","Finland","FI",{"type":49,"coordinates":50},"Point",[51,52],24.93545,60.16952,{"lat":52,"lon":51},[55,57],{"name":56,"role":35,"phone":18,"phoneExt":18,"email":37},"Noora Carpén",{"name":58,"role":35,"phone":18,"phoneExt":18,"email":40},"Samuli Rautava, As. prof",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Otto Helve","Docent",[64,66],{"name":65,"class":6},"Karolinska Institutet",{"name":30,"class":6},"100533594","preterm-infant-intestinal-microbiota-development-and-maternal-fecal-transplant-100533594",false,"NCT06227845","Preterm Infant Intestinal Microbiota Development and Maternal Fecal Transplant","PREFLOR","Inclusion Criteria:\n\n* Pregnant women with preeclampsia or other risk factors of preterm labor (eg cervix insufficiency or placenta previa) between 29+0 - 34+0 weeks of pregnancy.\n* Either parent fluent in Finnish.\n\nExclusion Criteria:\n\n* Women with other significant medical conditions including acute infection, IBD, celiac disease.\n* Travelling outside the EU and use of antibiotics during the last 3 months.\n* Gestational diabetes with insulin medication.\n* Pregnant with multiples.","FEMALE","18 Years",{"count":77,"type":78},36,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to study if a oral maternal fecal transplant given to a premature infant born by cesarean section (CS) is safe. The investigators will also compare the gut microbiome of the infants to those born by CS and not received the transplant and to premature infants born vaginally.",[84],"Microbial Colonization",[86,24,87,88],"Premature infant","Cesarean section","Immune system development","NOT_YET_RECRUITING","2024-02-13",{"date":92,"type":93},"2024-02-15","ACTUAL",{"date":95,"type":78},"2024-02",{"date":97,"type":78},"2026-12",{"name":61,"class":6},1]