[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591020":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":57,"interventions":69,"overallOfficials":44,"centralContacts":77,"locations":83,"responsibleParty":108,"collaborators":111,"id":115,"slug":44,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":44,"enrollmentInfo":124,"targetDuration":44,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":86,"whyStopped":44,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"BMI at 24 months of age","Child's body mass index (BMI) at the age of 24 months","From enrollment to 24 months of age",[14,17,20,24,27,31,35,38,41],{"measure":15,"description":16,"timeFrame":12},"Height","Child's height at the age of 6, 12, 18, and 24 months",{"measure":18,"description":19,"timeFrame":12},"Weight","Child's weight at the age of 6, 12, 18, and 24 months",{"measure":21,"description":22,"timeFrame":23},"Growth velocity","Child's growth velocity at 2-3 months of age","From enrollment to 3 months of age",{"measure":25,"description":26,"timeFrame":12},"Child's microbiome","The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months",{"measure":28,"description":29,"timeFrame":30},"Mother's microbiome","The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age","From enrollment to 6 months after giving birth",{"measure":32,"description":33,"timeFrame":34},"Breast milk microbiome","The composition of breast milk's microbiome when the child is 2 and 6 months of age","From enrollment to 6 months of age",{"measure":36,"description":37,"timeFrame":34},"Hormonal levels","Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months",{"measure":39,"description":40,"timeFrame":34},"Inflammatory markers","Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months",{"measure":42,"description":43,"timeFrame":12},"Respiratory tract infections","Respiratory tract infections by the age of 24 months",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","Randomized, placebo-controlled trial","OTHER",{"masking":51,"maskingDescription":44,"whoMasked":52},"QUADRUPLE",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Synbiotic","ACTIVE_COMPARATOR","Bifidobacterium bifidum and human milk oligosaccharides (HMOs)",[63],"Dietary Supplement: Synbiotic Supplement",{"label":65,"type":66,"description":44,"interventionNames":67},"Placebo","PLACEBO_COMPARATOR",[68],"Other: Placebo",[70,74],{"type":71,"name":72,"description":61,"armGroupLabels":73,"otherNames":44},"DIETARY_SUPPLEMENT","Synbiotic Supplement",[59],{"type":49,"name":65,"description":75,"armGroupLabels":76,"otherNames":44},"Maltodextrin",[65],[78],{"name":79,"role":80,"phone":81,"phoneExt":44,"email":82},"Paula Tähtinen, MD, PhD","CONTACT","+358-2-3130746","paula.tahtinen@utu.fi",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku","RECRUITING","Turku","Valitse Maakunta.","20780","Finland","FI",{"type":93,"coordinates":94},"Point",[95,96],22.26869,60.45148,{"lat":96,"lon":95},[99,100,101,104,106],{"name":79,"role":80,"phone":81,"phoneExt":44,"email":82},{"name":44,"role":80,"phone":44,"phoneExt":44,"email":82},{"name":102,"role":103,"phone":44,"phoneExt":44,"email":44},"Erika Isolauri, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":79,"role":105,"phone":44,"phoneExt":44,"email":44},"SUB_INVESTIGATOR",{"name":107,"role":105,"phone":44,"phoneExt":44,"email":44},"Tuuli Vuorisalo, MD",{"type":103,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Erika Isolauri","Professor of Paediatrics",[112],{"name":113,"class":114},"Lallemand Health Solutions","INDUSTRY","100591020",false,"NCT06974994","Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation","Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation","ReCoverHealth","Inclusion Criteria:\n\nPregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.\n\nExclusion Criteria:\n\n* Chorioamnionitis\n* Pre-eclampsia and hepatogestosis\n* Suspected malformation or serious condition of the foetus and neonates\n* Serious infection or other conditions not permitting breast milk feeding","ALL","2 Hours",{"count":125,"type":126},125,"ESTIMATED","INTERVENTIONAL",[129],"NA","The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.",[132],"Healthy Newborn Infants",[134,135,136,137,138,139,140,141],"antibiotics","human milk oligosaccharides","probiotics","newborn","microbiome","microbiota","obesity","infectious diseases","2025-05-07",{"date":144,"type":145},"2025-05-16","ACTUAL",{"date":147,"type":145},"2024-05-08",{"date":149,"type":126},"2029-12",{"name":5,"class":6},1]