Diagnostic Value of Fecal Calprotectin in Gastrointestinal Disorders Versus Its Correlation With Endoscopic and Histopathological Findings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Diagnostic performance of fecal calprotectin
研究概览
简要总结
This prospective cross-sectional study aims to evaluate the diagnostic value of fecal calprotectin as a non-invasive biomarker in children with gastrointestinal disorders and to assess its correlation with endoscopic and histopathological findings at Assiut University Children Hospital.
详细描述
Gastrointestinal symptoms such as chronic abdominal pain, persistent diarrhea, and rectal bleeding are common reasons for referral to pediatric gastroenterology clinics. Distinguishing organic inflammatory disease from functional disorders remains a diagnostic challenge.
Fecal calprotectin is a non-invasive marker of intestinal inflammation. This study will include children aged 2 to 18 years with chronic or recurrent gastrointestinal symptoms who are scheduled for endoscopic evaluation. Fecal calprotectin levels will be measured and compared with endoscopic and histopathological findings to determine diagnostic performance, including sensitivity, specificity, and optimal cutoff values.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age 2 to 18 years
- •Chronic gastrointestinal symptoms of more than 4 weeks duration (chronic diarrhea, recurrent abdominal pain, rectal bleeding, unexplained weight loss, or failure to thrive)
- •Scheduled for upper gastrointestinal endoscopy and/or ileocolonoscopy with mucosal biopsy
- •Written informed consent from parents or legal guardians
排除标准
- •Age below 2 years
- •Use of NSAIDs, systemic corticosteroids, or antibiotics within 4 weeks before stool sampling
- •Documented acute gastrointestinal infection, surgical gastrointestinal bleeding, or intestinal parasitic infestation
- •Previous gastrointestinal surgery, known malignancy, chronic liver disease, chronic kidney disease, or cystic fibrosis
- •Refusal of parents or legal guardians to participate
- •Failure to obtain an adequate stool sample
研究组 & 干预措施
Single group: Children with gastrointestinal symptoms undergoing endoscopy
Children aged 2-18 years with chronic or recurrent gastrointestinal symptoms who will undergo fecal calprotectin measurement and endoscopic evaluation with mucosal biopsy as part of routine diagnostic work-up.
结局指标
主要结局
Diagnostic performance of fecal calprotectin
时间窗: Baseline
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve of fecal calprotectin for detecting mucosal inflammation, using endoscopic and histopathological findings as the reference standard.
次要结局
- Correlation with endoscopic findings(Baseline)
- Correlation with histopathological findings(Baseline)
- Optimal cutoff value of fecal calprotectin(Baseline)
研究者
Manar Helmy Mohamed
Resident Physician department of pediatrics
Assiut University