[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638747":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":98,"whyStopped":30,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"BioGaia AB","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic+ Vitamin D3","ACTIVE_COMPARATOR","C-section, active group",[13],"Dietary Supplement: Probiotic drops",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo+ Vitamin D3","PLACEBO_COMPARATOR","C-section, placebo group",[19],"Dietary Supplement: Placebo drops",{"label":21,"type":16,"description":22,"interventionNames":23},"Placebo+ Vitamin D3 open label group","Vaginal, placebo group",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Probiotic drops","Probiotic+vitamin D3 drops",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Placebo drops","Placebo+vitamin D3",[15,21],[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Sofia Nordh, PhD","CONTACT","+46 (0)8 555 293 00","son@biogaianewsciences.com",[42,56],{"facility":43,"status":30,"city":44,"state":30,"zip":30,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Helsinki University Hospital","Helsinki","Finland","FI",{"type":48,"coordinates":49},"Point",[50,51],24.93545,60.16952,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":30,"phoneExt":30,"email":30},"Samuli Rautava, MD",{"facility":57,"status":30,"city":58,"state":30,"zip":30,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Tampere University Hospital","Tampere",{"type":48,"coordinates":60},[61,62],23.78712,61.49911,{"lat":62,"lon":61},[65],{"name":66,"role":38,"phone":30,"phoneExt":30,"email":30},"Sauli Palmu, MD",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[70],{"name":71,"class":6},"Aurevia","100638747","influence-of-probiotics-on-early-gut-microbial-colonization-100638747",false,"NCT07608341","Influence of Probiotics on Early Gut Microbial Colonization","Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section","STORKIE","Inclusion Criteria:\n\nInfant born by planned C-section or vaginal born infant\n\nGestational age at birth ≥ 37±0 weeks to \\\u003C41 ±0 weeks\n\nInfant Apgar score 7-10, (5 minutes after birth)\n\nIntention to breastfeed the infant\n\nParents\u002Flegal guardians are \\>18 years\n\nParents\u002Flegal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples\n\nParents\u002Flegal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator\n\nParents\u002Flegal guardians are willing and able to give written informed consent for their and their infants participation in the study\n\nExclusion Criteria:\n\n\\>72 hours after birth when collecting the first faecal sample and given the first drops of study product\n\nInfants classified as small for gestational age (SGA), defined as birth weight \\\u003C -2 standard deviations (SD) for gestational age and sex according to national reference standards.\n\nInfants with birth of congenital malformations or anomalies\n\nInfants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)\n\nInfants requiring care in neonatal unit\n\nDisruption of amniotic membranes for \\>24 hours\n\nInfants consuming probiotics, including in infant formula\n\nMothers use of antibiotics during the last 14 days of pregnancy prior to delivery\n\nParticipation in other clinical studies\n\nAny other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results",true,"ALL","0 Days","3 Days",{"count":85,"type":86},150,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.\n\nAn intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.\n\nParticipants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires\u002Fdiaries. After the intervention period, there is an optional follow-up period for up to 3 years.",[92],"C-Section",[94,95,96,97],"microbiome","c-section","probiotic","gut microbiome","NOT_YET_RECRUITING","2026-05-19",{"date":101,"type":102},"2026-05-27","ACTUAL",{"date":104,"type":86},"2026-08-01",{"date":106,"type":86},"2030-08-01",{"name":5,"class":6},2]