[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537957":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotics","EXPERIMENTAL","Participants will recieve a multi-strain probiotic daily for 6 months",[13],"Dietary Supplement: Multistrain Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","SHAM_COMPARATOR","Participants will recieve maltodextrin daily for 6 months",[19],"Dietary Supplement: Placebo - maltodextrin",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Multistrain Probiotic",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo - maltodextrin","Participants will recieve placebo\u002F maltodextri daily for 6 months",[15],[31],{"facility":5,"status":32,"city":33,"state":25,"zip":25,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Oslo","Norway","NO",{"type":37,"coordinates":38},"Point",[39,40],10.74609,59.91273,{"lat":40,"lon":39},[43,48,52,54,56],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Magnhild P Kolsgaard, PhD","CONTACT","0047 41514045","uxpoma@ous-hf.no",{"name":49,"role":45,"phone":50,"phoneExt":25,"email":51},"Camilla Styffe Sæland, Master","004793257798","casael@ous-hf.no",{"name":44,"role":53,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":49,"role":55,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":57,"role":55,"phone":25,"phoneExt":25,"email":25},"Linh Dieu Ngo, Master",{"type":53,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Magnhild L. P. Kolsgaard","Dietitian, PhD",[62],{"name":63,"class":6},"Norwegian National Adivisory Unit on Rare Disorders","100537957","quality-of-life-and-gut-health-in-pediatric-patients-with-cystic-fibrosis-100537957",false,"NCT06284577","Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis","Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis","Inclusion criteria for WP1:\n\n* CFTR mutations eligible for treatment with ETI\n* Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024.\n* Included in the Norwegian CF Register and consented to participation in CF general research biobank\n\nExclusion criteria for WP1:\n\n* Other CFTR modulators commenced the last 6 months before inclusion\n* Use of probiotics or prebiotics last 2 months\n* Current pulmonary exacerbation\n\nInclusion criteria for WP2:\n\n* Age 3-18 years\n* CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months\n* Included in the Norwegian CF Register and consented to participation in CF general research biobank\n\nExclusion criteria for WP2:\n\n* CFTR modulators commenced the last 6 months before inclusion\n* Use of probiotics or prebiotics last 2 months\n* Current pulmonary exacerbation","ALL","2 Years","18 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"NA","The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.",[82],"Cystic Fibrosis in Children",[84,85,86,87,88,89,90],"Cystic Fibrosis","Children","Microbiota","Quality of life","Probiotic supplement","CFTR modulators","elexacaftor-tezacaftor-ivacaftor","2024-06-12",{"date":93,"type":94},"2024-06-13","ACTUAL",{"date":96,"type":94},"2024-01-02",{"date":98,"type":76},"2027-07-01",{"name":5,"class":6},1]