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NCT Number: NCT07637045

Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Rajhi University Hospital

Asyut, 71515, Egypt

Location contact

Randa Mahrous Roshdy, MSc

CONTACT

[email protected]

+201021584548

Randa Mahrous Roshdy, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urinary PGE-MUM Levels Discriminates Disease Activity in UC

    Time frame: 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).

Secondary outcomes

  1. Correlation between PGE-MUM and CRP

    Time frame: 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).

  2. Optimal PGE-MUM cut-off value for disease activity

    Time frame: 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).

  3. Correlation between PGE-MUM and Endoscopic/Histologic scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abd El Fadil Maghraby, MD

CONTACT

[email protected]

+201122871357

Randa Mahrous Roshdy, Master of Internal Medicine

CONTACT

[email protected]

+201021584548

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt

Acronym: PGE-MUM_UC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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