[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658838":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":26,"overallOfficials":39,"centralContacts":44,"locations":26,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":26,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Mean fecal calprotectin level","Mean fecal calprotectin concentration measured by ELISA in µg\u002Fg.","Baseline",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Proportion of children with elevated fecal calprotectin","Proportion of children with fecal calprotectin level above the laboratory reference range.",{"measure":18,"description":19,"timeFrame":12},"Proportion of children with abnormal intestinal ultrasound findings","Proportion of children showing bowel-wall thickening or increased vascularity on intestinal ultrasound.",{"measure":21,"description":22,"timeFrame":12},"Mean SLEDAI-2K score","Mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.",{"measure":24,"description":25,"timeFrame":12},"Mean bowel wall thickness on ultrasound","Mean bowel wall thickness in millimeters measured by intestinal ultrasound.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_CONTROL","CROSS_SECTIONAL","Juvenile systemic lupus erythematosus is a chronic multisystem autoimmune disease. Gastrointestinal involvement may be under-recognized and can be subclinical.\n\nThis observational study will measure fecal calprotectin and perform intestinal ultrasound in children with JSLE and age- and sex-matched healthy controls to assess subclinical gastrointestinal involvement.","Children with juvenile systemic lupus erythematosus and age- and sex-matched healthy controls attending Assiut University Children Hospital.",[33,36],{"label":34,"type":26,"description":35,"interventionNames":26},"Juvenile Systemic Lupus Erythematosus","Children with JSLE according to SLICC criteria with disease duration of at least 3 months.",{"label":37,"type":26,"description":38,"interventionNames":26},"Healthy Controls","Age- and sex-matched healthy children.",[40],{"name":41,"affiliation":42,"role":43},"Mostafa s Khalaf, prof","Pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Manar k M, Resident","CONTACT","+20 11 49443518","mnark024@gmail.com",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Manar Kamal Mostafa Ahmed","Resident Physician, Department of Pediatrics","100658838","subclinical-gastrointestinal-involvement-in-juvenile-systemic-lupus-erythematosus-100658838",false,"NCT07858461","Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus","Evaluation of Subclinical Gastrointestinal Involvement in Juvenile Systemic Lupus Erythematosus at Assiut University Children Hospital","Inclusion Criteria:\n\n* Children less than 18 years of age\n* Diagnosis of juvenile systemic lupus erythematosus according to SLICC criteria\n* Disease duration of at least 3 months\n* Age- and sex-matched healthy controls\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* \\- Established diagnosis of inflammatory bowel disease or other primary gastrointestinal disorder\n* Significant gastrointestinal manifestations (persistent abdominal pain, diarrhea, vomiting, GI bleeding, significant unexplained weight loss)\n* Active gastrointestinal infection within the preceding 4 weeks\n* Antibiotics, probiotics, or NSAIDs within the 2 weeks preceding stool sample collection\n* Other autoinflammatory or overlapping autoimmune diseases\n* Chronic liver or renal disease unrelated to JSLE",true,"ALL","1 Year","18 Years",{"count":66,"type":67},60,"ESTIMATED","OBSERVATIONAL","This cross-sectional case-control study aims to evaluate fecal calprotectin levels and intestinal ultrasound findings for the detection of subclinical gastrointestinal involvement in children with juvenile systemic lupus erythematosus compared with healthy controls.",[71,72],"Systemic Lupus Erythematosus","Gastrointestinal Diseases",[74,75,76,77,78,79],"Juvenile systemic","lupus erythematosus","Fecal calprotectin","Intestinal ultrasound","Subclinical gastrointestinal involvement","Assiut","NOT_YET_RECRUITING","2026-09-29",{"date":83,"type":84},"2026-10-05","ACTUAL",{"date":86,"type":67},"2026-09-30",{"date":88,"type":67},"2028-02-20",{"name":5,"class":6}]