Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity (PGE-MUM_UC)
Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires regular monitoring of disease activity. Currently, assessment depends on invasive colonoscopy or clinical scores that may not accurately reflect intestinal inflammation. This study aims to evaluate whether urinary Prostaglandin E-Major Metabolite (PGE-MUM) can serve as a non-invasive biomarker to discriminate disease activity in patients with ulcerative colitis.
This cross-sectional study will be conducted at Al-Rajhi University Hospital, Assiut University, Egypt.This study plans to enroll 114 adult patients (≥18 years) with confirmed UC diagnosis, divided into two equal groups: active disease and remission (57 patients each). Disease activity will be assessed using the Mayo Endoscopic Score (MES) and Clinical Activity Index (CAI). Urine samples will be collected from all participants to measure PGE-MUM levels. Blood samples will be tested for CRP, CBC, albumin, and creatinine. Colonoscopy with biopsy will be performed for endoscopic scoring and histopathological assessment using Geboes score.
The primary outcome is to establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with UC. Secondary outcomes include comparing PGE-MUM with CRP, determining the optimal cut-off value, and correlating PGE-MUM levels with MES and Geboes score.
If successful, urinary PGE-MUM could provide a simple, non-invasive, and cost-effective method for monitoring UC activity in the Egyptian healthcare setting, reducing the need for frequent colonoscopies and overcoming cultural barriers associated with stool collection.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Randa Mahrous Roshdy, Master of Internal Medicine
- 电话号码:+201021584548
- 邮箱:randa011188@med.aun.edu.eg
研究联系人备份
- 姓名:Ahmed Abd El Fadil Maghraby, MD
- 电话号码:+201122871357
- 邮箱:dr_magraby@aun.edu.eg
学习地点
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Asyut、埃及、71515
- Al-Rajhi University Hospital
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接触:
- Randa Mahrous Roshdy, MSc
- 电话号码:+201021584548
- 邮箱:randa011188@med.aun.edu.eg
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副研究员:
- Randa Mahrous Roshdy, MSc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adult patients aged ≥18 years
- Confirmed diagnosis of Ulcerative Colitis based on clinical, endoscopic, and histopathological criteria
- Active disease (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4) OR remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
- Willing and able to provide written informed consent
Exclusion Criteria:
- Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)
- History of colectomy
- Current smokers
- Chronic lung disease
- Malignancy
- Use of laxatives or NSAIDs within 2 weeks prior to enrollment
- Chronic kidney disease
- Pregnancy or lactation
- Active infection
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
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Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Urinary PGE-MUM Levels Discriminates Disease Activity in UC
大体时间:At the time of enrollment (single visit, cross-sectional assessment)
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To establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with ulcerative colitis.Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse).
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At the time of enrollment (single visit, cross-sectional assessment)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Correlation between PGE-MUM and CRP
大体时间:At enrollment
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To compare urinary PGE-MUM levels with serum C-reactive protein (CRP) levels in patients with active and remission UC. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Optimal PGE-MUM cut-off value for disease activity
大体时间:At enrollment
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To determine the optimal cut-off value of urinary PGE-MUM for discriminating active UC from remission using ROC curve analysis. Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse). |
At enrollment
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Correlation between PGE-MUM and Endoscopic/Histologic scores
大体时间:At enrollment
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The Mayo Endoscopic Score (MES) ranges from 0 to 3, with higher scores indicating more severe disease.
The Geboes histologic score ranges from 0 to 5.4, with higher scores indicating more severe inflammation.
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At enrollment
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合作者和调查者
调查人员
- 首席研究员:Mohamed Zain El Den Hafez, Professor、Assiut University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ASU_PhD_UC_2026_001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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