[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658820":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":36,"overallOfficials":46,"centralContacts":51,"locations":36,"responsibleParty":57,"collaborators":36,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":36,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":36,"enrollmentInfo":70,"targetDuration":36,"studyType":73,"phases":36,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":85,"whyStopped":36,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":36},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with endoscopic healing","Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD \\\u003C 3 in Crohn's disease.","12 to 16 weeks",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"Proportion of patients with histological healing","Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies.",{"measure":18,"description":19,"timeFrame":20},"Mean change in neutrophil-to-lymphocyte ratio","Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks.","Baseline and at 4 weeks",{"measure":22,"description":23,"timeFrame":20},"Mean change in C-reactive protein","Mean change in C-reactive protein (CRP) level from baseline to 4 weeks.",{"measure":25,"description":26,"timeFrame":20},"Mean change in CRP-to-albumin ratio","Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks.",{"measure":28,"description":29,"timeFrame":20},"Mean change in systemic immune-inflammation index","Mean change in systemic immune-inflammation index (SII) from baseline to 4 weeks.",{"measure":31,"description":32,"timeFrame":12},"Mean Mayo Endoscopic Score","Mean Mayo Endoscopic Score in patients with ulcerative colitis (range 0-3, higher scores indicate more severe endoscopic activity).",{"measure":34,"description":35,"timeFrame":12},"Mean SES-CD score","Mean Simple Endoscopic Score for Crohn's Disease (SES-CD) (higher scores indicate more severe endoscopic activity).",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","PROSPECTIVE","Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.\n\nBlood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.","Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.",[43],{"label":44,"type":36,"description":45,"interventionNames":36},"Single cohort: Adult IBD Patients","Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes.",[47],{"name":48,"affiliation":49,"role":50},"Mohamed Z Hagez, prof","Internal Medicine Department, Assiut University Hospitals","STUDY_CHAIR",[52],{"name":53,"role":54,"phone":55,"phoneExt":36,"email":56},"Yehia M Alaa, Resident","CONTACT","01552751879","Yehia.18313599@med.aun.edu.eg",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Yehia Mohamed alaa aldin saad ali","Resident Physician, Department of Internal Medicine","100658820","early-changes-in-inflammatory-indices-and-healing-in-ibd-100658820",false,"NCT07855055","Early Changes in Inflammatory Indices and Healing in IBD","Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Age 18 years or older\n* Confirmed diagnosis of ulcerative colitis or Crohn's disease\n* Objective evidence of active disease at baseline\n* Planned initiation or escalation of IBD treatment\n* Baseline CBC with differential, CRP, and serum albumin available\n* Planned follow-up assessment at approximately 12-16 weeks\n* Planned follow-up colonoscopy with mucosal biopsies at approximately 12-16 weeks\n* Written informed consent\n\nExclusion Criteria:\n\n* Active infection\n* Recent major surgery\n* Malignancy\n* Hematological malignancy or disorder substantially altering leukocyte or platelet counts\n* Significant uncontrolled liver disease\n* Severe renal disease expected to substantially affect inflammatory markers\n* Recent blood transfusion\n* Pregnancy\n* Concomitant autoimmune inflammatory disease\n* Systemic corticosteroids used for another indication\n* Acute severe infection around the time of blood sampling\n* Inadequate follow-up or missing essential data","ALL","18 Years",{"count":71,"type":72},138,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.",[76,77,78],"Inflammatory Bowel Disease","Ulcerative Colitis","Crohn Disease",[80,81,82,83,84],"Inflammatory bowel disease","Neutrophil-to-lymphocyte ratio","C-reactive protein","Endoscopic healing","Assiut","NOT_YET_RECRUITING","2026-09-27",{"date":88,"type":89},"2026-10-02","ACTUAL",{"date":91,"type":72},"2026-09-30",{"date":93,"type":72},"2028-02-10",{"name":5,"class":6}]