Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity

Starting soon

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07637045

Run by

Assiut University

People needed

114

Starts

2026-08-01

Expected to finish

2027-06-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Al-Rajhi University Hospital — Asyut, Egypt

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.