[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656205":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":32,"overallOfficials":45,"centralContacts":50,"locations":32,"responsibleParty":56,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":32,"maxAge":68,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":32,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":84,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":32},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical remission rate after exclusive enteral nutrition","Proportion of patients achieving clinical remission defined as Pediatric Crohn's Disease Activity Index (PCDAI) score less than 10 after 6-8 weeks of Exclusive Enteral Nutrition with Modulen IBD.","At week 6-8",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Maintenance of remission","Proportion of patients remaining in clinical remission (PCDAI \\\u003C10) at 6 months and 12 months","At 6 months and at 12 months",{"measure":19,"description":20,"timeFrame":21},"Change in weight","Change in body weight (kg) from baseline.","From baseline to week 6-8, 6 months, and 12 months",{"measure":23,"description":24,"timeFrame":21},"Change in BMI z-score","Change in Body Mass Index z-score from baseline.",{"measure":26,"description":27,"timeFrame":21},"Change in inflammatory markers","Change in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels from baseline.",{"measure":29,"description":30,"timeFrame":31},"Relapse rate","Proportion of patients experiencing clinical relapse (PCDAI ≥10) during follow-up.","Up to 12 months",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","Exclusive Enteral Nutrition (EEN) is recommended as first-line therapy for induction of remission in mild-to-moderate pediatric Crohn's disease. Modulen IBD is a polymeric formula enriched with TGF-β2.\n\nThis observational study will include children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease. Patients receiving Modulen IBD for Exclusive Enteral Nutrition followed by Partial Enteral Nutrition will be compared with those not receiving the formula. Clinical remission, nutritional status, growth parameters, and laboratory markers will be assessed at predefined time points up to 12 months.","Children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease attending the Pediatric Gastroenterology, Hepatology and Clinical Nutrition Unit at Assiut University Children Hospital.",[39,42],{"label":40,"type":32,"description":41,"interventionNames":32},"Modulen group","Children with Crohn's disease receiving Exclusive Enteral Nutrition followed by Partial Enteral Nutrition with Modulen IBD.",{"label":43,"type":32,"description":44,"interventionNames":32},"Non-Modulen group","Children with Crohn's disease not receiving Modulen IBD formula.",[46],{"name":47,"affiliation":48,"role":49},"Osama m El-Asheer, prof","pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[51],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Martina e Anwer, Resident","CONTACT","01229046462","martinaemad955@aun.edu.eg",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","MartinaEmad","Resident Physician","100656205","modulen-ibd-for-induction-and-maintenance-of-remission-in-pediatric-crohns-disease-100656205",false,"NCT07821645","Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease","Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease","Inclusion Criteria:\n\n* \\- Age younger than 18 years\n* Diagnosis of Crohn's disease according to clinical, endoscopic, histopathological, and radiological findings\n* Mild to moderate active Crohn's disease\n* Newly diagnosed or active patients commencing Exclusive Enteral Nutrition therapy\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* \\- Age 18 years or older\n* Severe complicated Crohn's disease requiring immediate surgery\n* Other chronic gastrointestinal diseases\n* Severe systemic illnesses affecting nutritional status\n* Inability to tolerate enteral nutrition\n* Poor compliance with Modulen therapy\n* Incomplete follow-up data","ALL","17 Years",{"count":70,"type":71},40,"ESTIMATED","OBSERVATIONAL","This prospective cohort study aims to evaluate the effectiveness of the specially prepared medical milk formula (Modulen IBD) in inducing and maintaining remission in children and adolescents with Crohn's disease at Assiut University Children Hospital.",[75,76,77],"Crohn Disease","Inflammatory Bowel Diseases","Pediatric Crohns Disease",[79,80,81,82,83],"Modulen IBD","Exclusive enteral nutrition","Pediatric Crohn's disease","PCDAI","Remission","NOT_YET_RECRUITING","2026-09-10",{"date":87,"type":88},"2026-09-16","ACTUAL",{"date":85,"type":71},{"date":91,"type":71},"2028-01-20",{"name":5,"class":6}]