Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity

NCT07637045 | Not Yet Recruiting

• 1 other identifier: ASU_PhD_UC_2026_001
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis; PGE-MUM; Urinary biomarker; Inflammatory Bowel Disease; Non-invasive biomarker

Outcome Measures

Primary Outcomes (1)

• 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.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)

Secondary Outcomes (3)

• Correlation between PGE-MUM and CRP

  At enrollment

• Optimal PGE-MUM cut-off value for disease activity

  At enrollment

• Correlation between PGE-MUM and Endoscopic/Histologic scores

  At enrollment

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Al-Rajhi University Hospital

Asyut, 71515, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mohamed Zain El Den Hafez, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randa Mahrous Roshdy, Master of Internal Medicine

CONTACT

+201021584548; randa011188@med.aun.edu.eg

Ahmed Abd El Fadil Maghraby, MD

CONTACT

+201122871357; dr_magraby@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student in Internal Medicine

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)