[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535750":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":113,"collaborators":42,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":42,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":42,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":60,"whyStopped":42,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton pump inhibitor","ACTIVE_COMPARATOR","Omeprazole 1 mg\u002F kg and continuing nutrition containing cow's milk protein",[13],"Drug: Protein pump inhibitor.",{"label":15,"type":10,"description":16,"interventionNames":17},"Mother or infant diet","Mother on cow milk-protein-free diet if breastfeeding and infant on a hypoallergenic formula if bottle-fed.",[18],"Behavioral: Mother or infant diet",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Placebo medicine (appearing substantially like Omeprazole) 1mg\u002Fkg and continuing nutrition containing cow's milk protein",[24],"Drug: Placebo",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Protein pump inhibitor.","1 mg\u002Fkg \u002Fday",[9],[32],"Omeprazole",{"type":34,"name":15,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed",[15],[38],"Cow milk protein free diet",{"type":27,"name":20,"description":40,"armGroupLabels":41,"otherNames":42},"Placebo medicine (appearing substantially like Omeprazole) 1mg\u002F ml, and continuing nutrition containing cows' milk protein",[20],null,[44],{"name":45,"affiliation":46,"role":47},"Gitte Zachariassen, Professor","H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)","STUDY_DIRECTOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":42,"email":53},"Natalia K Barkholt, MD","CONTACT","+4521787136","Natalia.Barkholt@rsyd.dk",{"name":45,"role":51,"phone":55,"phoneExt":42,"email":56},"+4565413809","Gitte.Zachariassen@rsyd.dk",[58,83,101],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Paediatric Department, Hospital of Southern Jutland","RECRUITING","Aabenraa","Region Syddanmark","6200","Denmark","DK",{"type":67,"coordinates":68},"Point",[69,70],9.41741,55.04434,{"lat":70,"lon":69},[73,77,80],{"name":74,"role":51,"phone":75,"phoneExt":42,"email":76},"Natalia K Barkholt","+46 21787136","natalia.barkholt@rsyd.dk",{"name":78,"role":51,"phone":42,"phoneExt":42,"email":79},"Gitte Zachariassen","gitte.zachariassen@rsyd.dk",{"name":81,"role":82,"phone":42,"phoneExt":42,"email":42},"Natalia K Barkholt, Dr","PRINCIPAL_INVESTIGATOR",{"facility":84,"status":85,"city":86,"state":62,"zip":87,"country":64,"countryCode":65,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Børnelægecentret v\u002FKasper Dalby","NOT_YET_RECRUITING","Odense","5000",{"type":67,"coordinates":89},[90,91],10.38831,55.39594,{"lat":91,"lon":90},[94,98,100],{"name":95,"role":51,"phone":96,"phoneExt":42,"email":97},"Kasper Dalby","+45 65 90 80 60","blcfyn@gmail.com",{"name":99,"role":51,"phone":42,"phoneExt":42,"email":76},"Natalia Barkholt",{"name":95,"role":82,"phone":42,"phoneExt":42,"email":42},{"facility":102,"status":85,"city":86,"state":62,"zip":87,"country":64,"countryCode":65,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"H.C Andersen Childrens' Hospital",{"type":67,"coordinates":104},[90,91],{"lat":91,"lon":90},[107,111,112],{"name":108,"role":51,"phone":109,"phoneExt":42,"email":110},"Josefine Gradman","+45 29241375","Josefine.Gradman@rsyd.dk",{"name":99,"role":51,"phone":42,"phoneExt":42,"email":76},{"name":108,"role":82,"phone":42,"phoneExt":42,"email":42},{"type":114,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100535750","phase-4-treatment-of-gastroesophageal-reflux-disease-in-infants-100535750",false,"NCT06255886","Treatment of Gastroesophageal Reflux Disease in Infants","Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants diagnosed with gastroesophageal reflux disease (GERD)\n* Age \\\u003C 1 year at the time of referral\n* Age \\>1 month at start of treatment\n* At least 3 reflux episodes\u002Fdaily in average\n* At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort\u002Firritability, problems gaining weight\u002F weightloss, rejects the breast or bottle, apnea, back-arching.\n\nExclusion Criteria:\n\n* Children with diagnosed or suspected syndrome \u002Fgenetic disorder\n* Congenital malformations (minor deformities are excepted)\n* Abdominal surgery\n* Metabolic disease\n* Treatment with proton pump inhibitor within the last week\n* Allergy for proton pump inhibitors\n* Allergy for cow milk protein\n* Infants on Cow's milk free diet","ALL","1 Month","1 Year",{"count":126,"type":127},96,"ESTIMATED","INTERVENTIONAL",[130],"PHASE4","Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)",[133,134],"Gastroesophageal Reflux","Infant, Newborn, Diseases",[136,137,138,139,140,141,142,143,144,9,145,32],"Reflux","Infants","GERD","GER","GORD","GOR","Cow milk protein","Bovine milk protein","CMP","PPI","2025-11-17",{"date":148,"type":149},"2025-11-20","ACTUAL",{"date":151,"type":149},"2025-10-27",{"date":153,"type":127},"2026-12-26",{"name":5,"class":6},3]