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Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity (PGE-MUM_UC)

2026年6月9日 更新者:Randa Mahrous Roshdy、Assiut University

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

尚未招聘

研究类型

观察性的

注册 (估计的)

114

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Asyut、埃及、71515
        • Al-Rajhi University Hospital
        • 接触:
        • 副研究员:
          • Randa Mahrous Roshdy, MSc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult Egyptian patients with confirmed diagnosis of Ulcerative Colitis attending the Gastroenterology Clinic at Al-Rajhi University Hospital, Assiut University.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Active UC Group
Patients with active ulcerative colitis (Mayo Endoscopic Score 2-3, Clinical Activity Index ≥4)
Remission UC
Patients with ulcerative colitis in remission (Mayo Endoscopic Score 0-1, Clinical Activity Index ≤3)

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
Urinary PGE-MUM Levels Discriminates Disease Activity in UC
大体时间:At the time of enrollment (single visit, cross-sectional assessment)
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).
At the time of enrollment (single visit, cross-sectional assessment)

次要结果测量

结果测量
措施说明
大体时间
Correlation between PGE-MUM and CRP
大体时间:At enrollment

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
Optimal PGE-MUM cut-off value for disease activity
大体时间:At enrollment

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
Correlation between PGE-MUM and Endoscopic/Histologic scores
大体时间:At enrollment
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.
At enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mohamed Zain El Den Hafez, Professor、Assiut University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This is an observational cross-sectional study with local ethical approval only. Data sharing is not planned.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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