[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536391":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":57,"locations":66,"responsibleParty":97,"collaborators":47,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":47,"enrollmentInfo":112,"targetDuration":47,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":47,"overallStatus":69,"whyStopped":47,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Copenhagen Studies on Asthma in Childhood","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT (Fecal microbiota transplantation)","ACTIVE_COMPARATOR","Mother-to-infant fecal microbiota transplantation",[13],"Biological: Microbiome restoration - FMT",{"label":15,"type":10,"description":16,"interventionNames":17},"FVT (Fecal virome transplantation)","Mother-to-infant fecal virome transplantation",[18],"Biological: Microbiome restoration - FVT",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Inactive solution buffer placebo",[24],"Biological: Placebo",{"label":26,"type":6,"description":27,"interventionNames":28},"Vaginal control group","Non-randomized control group used for secondary outcomes comparisons.",[29],"Other: Vaginal birth, untreated control",[31,38,44,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","Microbiome restoration - FMT","Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.",[9],[37],"Fecal Microbiota Transplantation",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Microbiome restoration - FVT","Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.",[15],[43],"Fecal Virome Transplantation",{"type":32,"name":20,"description":45,"armGroupLabels":46,"otherNames":47},"Inactive solution buffer",[20],null,{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":47},"Vaginal birth, untreated control","No intervention. This group is for secondary outcomes comparisons.",[26],[53],{"name":54,"affiliation":55,"role":56},"Klaus Bønnelykke, MD, PhD","Head of COPSAC","STUDY_CHAIR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":47,"email":62},"Jakob Stokholm, MD, PhD","CONTACT","+45 38677360","stokholm@copsac.com",{"name":64,"role":60,"phone":61,"phoneExt":47,"email":65},"Kaare D. Tranæs, Msc","kaare.tranaes@dbac.dk",[67,83],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Copsac, DBAC","RECRUITING","Gentofte Municipality","Copenhagen","2820","Denmark","DK",{"type":76,"coordinates":77},"Point",[78,79],12.54601,55.74903,{"lat":79,"lon":78},[82],{"name":59,"role":60,"phone":61,"phoneExt":47,"email":62},{"facility":84,"status":85,"city":71,"state":47,"zip":86,"country":73,"countryCode":74,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Rigshospitalet","NOT_YET_RECRUITING","2100",{"type":76,"coordinates":88},[89,90],12.56553,55.67594,{"lat":90,"lon":89},[93],{"name":94,"role":60,"phone":95,"phoneExt":47,"email":96},"Hanne Hegaard, Professor","+45 27583632","Hanne.Kristine.Hegaard@regionh.dk",{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"SPONSOR_INVESTIGATOR","Jakob Stokholm","Professor PhD","100536391","phase-1-restoration-of-the-gut-microbiome-after-cesarean-section-100536391",false,"NCT06264219","Restoration of the Gut Microbiome After Cesarean Section","\"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)\" - A Double-blinded Randomized Placebo-controlled Trial","RestoreGut","Inclusion Criteria:\n\n* Gestational age \\\u003C week 38+0 days\n* Proficient in spoken\u002Fwritten Danish\n* Single pregnancy (no twins or triplets)\n* Pre-pregnancy BMI between 18.5 and 35 kg\u002Fm2\n* No chronic intestinal, endocrine, cardiac, or kidney disorders\n* No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)\n* No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.\n* Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).\n\nExclusion Criteria:\n\nMaternal:\n\n* Use of antibiotics within one month of stool donation\n* Acute gastroenteritis within one month of stool donation\n* Use of antibiotics within one month of birth\n* Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations (\"Regler for tappepauser\" - blooddonor.dk)\n* Positive test results for pathogens during donor material screening.\n* Antibiotic treatment at birth (vaginal births only)\n* Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.\n\nInfant:\n\n* Instances of major birth defects or intrauterine growth retardation (IUGR)\n* Infants requiring pediatric support at the time of transplant administration",true,"FEMALE","18 Years",{"count":113,"type":114},80,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.",[120],"Microbial Colonization","2026-06-25",{"date":123,"type":124},"2026-06-29","ACTUAL",{"date":126,"type":124},"2024-08-02",{"date":128,"type":114},"2027-08-30",{"name":99,"class":6},2]