[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499429":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":56,"overallOfficials":69,"centralContacts":76,"locations":85,"responsibleParty":106,"collaborators":108,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":30,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":87,"whyStopped":30,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Beneo-Institute","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Fever","Number of febrile days (peak temperature of forehead at least 38.0°C)","Data collected continuously from enrollment until end of intervention (up to 90 days).",{"measure":14,"description":15,"timeFrame":12},"Absenteeism","Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"Beneficial colonization","Changes in fecal microbiota by 16S rRNA Sequencing","Stool sample collected at baseline and after 90 days intervention period",{"measure":22,"description":23,"timeFrame":12},"Stool consistency","Hard, formed, soft and watery stools will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale",{"measure":25,"description":26,"timeFrame":12},"Stool frequency","Number of defecations will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale",{"measure":28,"description":29,"timeFrame":12},"Caretaker´s absenteeism from work","Number of work days missed by the parents",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":36,"maskingDescription":30,"whoMasked":37},"QUADRUPLE",[38,39,40,41],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Experimental formula group","EXPERIMENTAL","Follow-on formula supplemented with a novel prebiotic combination",[49],"Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers",{"label":51,"type":52,"description":53,"interventionNames":54},"Control formula group","PLACEBO_COMPARATOR","Follow-on formula not supplemented",[55],"Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers",[57,64],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DIETARY_SUPPLEMENT","New prebiotic follow-on formula, randomly assigned to healthy toddlers","Standard follow-on formula administered orally",[45],[63],"supplemented with prebiotics",{"type":58,"name":65,"description":60,"armGroupLabels":66,"otherNames":67},"Standard follow-on formula, randomly assigned to healthy toddlers",[51],[68],"not supplemented with prebiotics",[70,74],{"name":71,"affiliation":72,"role":73},"Yvan Vandenplas, Prof.","Universitair Ziekenhuis Brussel","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":72,"role":73},"Koen Huysentruyt, Prof.",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":30,"email":81},"Stephan Theis, Dr","CONTACT","+496359803287","Stephan.Theis@beneo.com",{"name":83,"role":79,"phone":30,"phoneExt":30,"email":84},"Maria Pudenz, Dr.","maria.pudenz@beneo.com",[86],{"facility":72,"status":87,"city":88,"state":30,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"RECRUITING","Brussels","1090","Belgium","BE",{"type":93,"coordinates":94},"Point",[95,96],4.34878,50.85045,{"lat":96,"lon":95},[99,103],{"name":100,"role":79,"phone":101,"phoneExt":30,"email":102},"Hanne Delcourt, MD","02 474 95 69","hanne.delcourt@uzbrussel.be",{"name":104,"role":79,"phone":101,"phoneExt":30,"email":105},"Amy De Waele, Studiecoördinator","amy.dewaele@uzbrussel.be",{"type":107,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[109],{"name":72,"class":110},"OTHER","100499429","prebiotic-effects-in-healthy-toddlers-100499429",false,"NCT05783141","Prebiotic Effects in Healthy Toddlers","Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers","PrebiKidz","Inclusion Criteria:\n\n1. Child is healthy at the time of pre-examination\n2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention\n3. Child attends a daycare center at the time of pre examination for at least 50%.\n4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)\n5. Weight for height z-score \\>-2 and \\\u003C2 SD based on Flemish growth charts\n6. Child and legal guardian are able and willing to follow the study instructions\n7. Child is suitable for participation in the study according to the investigator\u002F study personnel\n8. Informed written consent given by parent \u002F legal guardian\n\nExclusion Criteria:\n\n1. No legal guardian's command of any local language\n2. Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)\n3. Child is suffering from congenital or acquired immunodeficiency\n4. Food allergies or intolerances\n5. Child is currently breast-fed more than once daily\n6. Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)\n7. Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and\u002For GOS\u002FFOS\u002FHMO is allowed.\n8. Child is suffering from an infection at the time of pre examination or previous 7 days\n9. Child is currently involved or will be involved in another clinical or food study\n10. Child is not suitable for participation in the study according to the study personnel´s opinion",true,"ALL","10 Months","36 Months",{"count":124,"type":125},342,"ESTIMATED","INTERVENTIONAL",[128],"NA","The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.",[131,132],"Child Development","Diet, Healthy",[134,135,136],"Microbiota","Prebiota","Child´s health","2024-09-05",{"date":139,"type":140},"2024-09-19","ACTUAL",{"date":142,"type":140},"2023-10-01",{"date":144,"type":125},"2025-09",{"name":5,"class":6},1]