[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619678":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","The control groups gets no Limosilactobacillus reuteri",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group","EXPERIMENTAL","The intervention group gets the two probiotic Limosilactobacillus reuteri strains",[19],"Dietary Supplement: Two probiotic Limosilactobacillus reuteri strains",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Two probiotic Limosilactobacillus reuteri strains","Each participant in this intervention group gets 5 drops per day, containing the two probiotic Limosilactobacillus reuteri strains and 400 IU of Vitamin D",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Each participant in this intervention group gets 5 drops per day, containing only 400 IU of Vitamin D.",[9],[32],{"name":33,"affiliation":5,"role":34},"Koen Huysentruyt, Pediatric Gastroenterologist","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+32 02\u002F476.37.17","koen.huysentruyt@uzbrussel.be",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Leontien Depoorter, Resident Pediatric Pulmonology","+32 02\u002F801.25.58","Leontien.Depoorter@uzbrussel.be",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"RECRUITING","Jette","Brussels Capital","1090","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],4.33419,50.87309,{"lat":56,"lon":55},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[61],{"name":62,"class":63},"BioGaia AB","INDUSTRY","100619678","preventive-effect-of-a-dietary-supplement-with-two-probiotic-limosilactobacillus-reuteri-strains-on-excessive-crying-and-colic-in-healthy-newborns-100619678",false,"NCT07347743","Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.","Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.","ProtectPrevent","Inclusion Criteria:\n\n1. Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.\n2. Infant is healthy at the time of pre-examination.\n3. Infant is aged between 1 and 14 days old at the time of inclusion.\n4. Legal guardian(s) are able and willing to follow the study instructions\n5. Infant is suitable for participation in the study according to the investigator\u002F study personnel\n6. Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).\n7. Informed written consent given by parent \u002F legal guardian\n\nExclusion Criteria:\n\n1. No legal guardian's command of any local language\n2. Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)\n3. Infant is suffering from congenital or acquired immunodeficiency\n4. Infant is suffering from an infection at the time of pre-examination or previous 7 days\n5. Infant is admitted post-partum to the neonatal intensive care unit\n6. Infant is not suitable for participation in the study according to the study personnel´s opinion",true,"ALL","1 Day","14 Days",{"count":77,"type":78},768,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying\u002Ffussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.",[84,85,86],"Colic","Healthy Infants","Eczema Atopic Dermatitis",[88,89,90,91,92,93,94],"Preventive effect","Limosilactobacillus reuteri","L. reuteri","crying","colic","healthy infants","newborns","2026-02-16",{"date":97,"type":98},"2026-02-19","ACTUAL",{"date":100,"type":98},"2026-01-31",{"date":102,"type":78},"2028-12",{"name":5,"class":6},1]