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. We plan 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis (UC)

• Study Type: Observational
• Enrollment (Estimated): 114

Contacts and Locations

• Study Contact: Name: Randa Mahrous Roshdy, Master of Internal Medicine; Phone Number: +201021584548; Email: randa011188@med.aun.edu.eg
• Study Contact Backup: Name: Ahmed Abd El Fadil Maghraby, MD; Phone Number: +201122871357; Email: dr_magraby@aun.edu.eg

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Al-Rajhi University Hospital
    • Contact: Randa Mahrous Roshdy, MSc; Phone Number: +201021584548; Email: randa011188@med.aun.edu.eg
    • Sub-Investigator: Randa Mahrous Roshdy, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary PGE-MUM Levels Discriminates Disease Activity in UC	To establish urinary PGE-MUM as a validated discriminatory biomarker for distinguishing active disease from remission in Egyptian patients with ulcerative colitis.	At the time of enrollment (single visit, cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between PGE-MUM and CRP	To compare urinary PGE-MUM levels with serum C-reactive protein (CRP) levels in patients with active and remission UC.	At enrollment
Optimal PGE-MUM cut-off value for disease activity	To determine the optimal cut-off value of urinary PGE-MUM	At enrollment
Correlation between PGE-MUM and Endoscopic/Histologic scores	To correlate urinary PGE-MUM levels with Mayo Endoscopic Score (MES) and Geboes histologic score.	At enrollment

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohamed Zain El Den Hafez, Professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Urinary biomarker; PGE-MUM; Non-invasive biomarker
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: ASU_PhD_UC_2026_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an observational cross-sectional study with local ethical approval only. Data sharing is not planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No