[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554918":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":33,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"Control group","NO_INTERVENTION",null,{"label":13,"type":14,"description":15,"interventionNames":16},"Probiotic group","EXPERIMENTAL","Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Baby contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)",[17],"Dietary Supplement: Probactiol Baby",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","Probactiol Baby","Dietary Supplement: Probactiol Mini 6 droplets of Probactiol Mini daily intake for 13 months",[13],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"An Boudewyns, Prof","CONTACT","003238214791","An.Boudewyns@uza.be",{"name":31,"role":27,"phone":11,"phoneExt":11,"email":32},"Joke Van Malderen, Ir","joke.vanmalderen@uantwerpen.be",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Hospital Antwerp","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":43,"coordinates":44},"Point",[45,46],4.44504,51.15662,{"lat":46,"lon":45},[49,51],{"name":50,"role":27,"phone":11,"phoneExt":11,"email":11},"An Boudewyns, Prof. Dr.",{"name":52,"role":53,"phone":11,"phoneExt":11,"email":11},"Joke Van Malderen, Ir.","SUB_INVESTIGATOR",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[57],{"name":58,"class":6},"Universiteit Antwerpen","100554918","respiratory-tract-microbiome-and-probiotics-in-children-with-cleft-palate-100554918",false,"NCT06505330","Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate","Study of the Effects of Probiotics on the Upper Respiratory Tract Microbiome and the Prevention of Otitis Media With Effusion in Children With Cleft Palate","Inclusion Criteria:\n\n* cleft palate \\& lip (uni\u002Fbilateral) or cleft palate\n* No syndromal disorders\n\nExclusion Criteria:\n\n* syndromal disorder\n* history of ventilation tube placement","ALL","6 Months","2 Years",{"count":70,"type":71},40,"ESTIMATED","INTERVENTIONAL",[74],"NA","Otitis media with effusion (OME) involves fluid accumulation in the middle ear without infection, sometimes causing discomfort and hearing loss in children. Persistent middle ear fluid lasting over 3 months may require treatment, including placement of ventilation tubes if it affects hearing.\n\nChildren with a cleft palate are at higher risk for otorrea after ventilation tube placement. Treatment typically involves antibiotic drops and ear cleaning by an ENT doctor, often requiring repeated visits, which may impact quality of life for both the child and the parents.\n\nThe mouth, throat, and nose harbor bacteria that can influence ear infections. This study aims to determine if probiotics can alter the bacteria in the nasopharynx and middle ear fluid and reduce the number of episodes of eardischarge following ventilation tube placement in children with cleft palate.\n\nUsing Lacticaseibacillus rhamnosus GG and Bifidobacterium lactis BB-12 from Bactiol® Baby (Metagenics), patients will be divided into two groups: one receiving probiotic drops and one not. The study will assess if probiotics can reduce the number of episodes with ear discharge in children with cleft palate, by examining the following:\n\n1. The airway microbiome composition in children with cleft palates.\n2. Whether oral probiotics can reduce the number and duration of ear discharge episodes.",[77,78],"Otitis Media in Children","Cleft Palate Children",[80,81,82,83,84],"otitis media","upper respiratory tract microbiome","cleft palate","probiotics","Lacticaseibacillus rhamnosus GG","2024-07-10",{"date":87,"type":88},"2024-07-17","ACTUAL",{"date":90,"type":88},"2024-06-24",{"date":92,"type":71},"2028-06-24",{"name":5,"class":6},1]