Ulcerative Colitis (UC)PGE-MUM_UCNCT07637045
Urinary PGE-MUM as a Marker for Ulcerative Colitis Activity
An observational study of Ulcerative Colitis (UC), run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Egyptian patients with confirmed diagnosis of Ulcerative Colitis attending the Gastroenterology Clinic at Al-Rajhi University Hospital, Assiut University.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic kidney disease
- Pregnancy or lactation
- Active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Rajhi University Hospital
Asyut, 71515
Randa Mahrous Roshdy, MSc, +201021584548, randa011188@med.aun.edu.eg
Randa Mahrous Roshdy, MSc
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the time of enrollment (single visit, cross-sectional assessment)
Secondary outcomes (3)
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.
Disease activity is assessed using the Mayo Endoscopic Score (MES, 0-3; higher=worse) and Clinical Activity Index (CAI, 0-19; higher=worse).
Measured: At enrollment
Optimal PGE-MUM cut-off value for disease activity
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).
Measured: At enrollment
Correlation between PGE-MUM and Endoscopic/Histologic scores
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Mahrous Roshdy, Assiut University
- Investigators
- Mohamed Zain El Den Hafez, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637045
- Sponsor's protocol ID
- ASU_PhD_UC_2026_001
- Acronym
- PGE-MUM_UC
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational cross-sectional study with local ethical approval only. Data sharing is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Prostaglandin E-Major Metabolite (PGE-MUM) Discriminates Disease Activity in Ulcerative Colitis: A Cross-Sectional Study From Egypt
- ClinicalTrials.gov ID
- NCT07637045
- Acronym / sponsor ID
- PGE-MUM_UC / ASU_PhD_UC_2026_001
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, PGE-MUM, Urinary biomarker, Inflammatory Bowel Disease, Non-invasive biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Egyptian patients with confirmed diagnosis of Ulcerative Colitis attending the Gastroenterology Clinic at Al-Rajhi University Hospital, Assiut University.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with other types of colitis (e.g., Crohn's disease, infectious colitis, ischemic colitis)
- History of colectomy
- Current smokers
- Chronic lung disease
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Correlation between PGE-MUM and CRP
Time frame: At enrollment
Optimal PGE-MUM cut-off value for disease activity
Time frame: At enrollment
Correlation between PGE-MUM and Endoscopic/Histologic scores
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. This is an observational cross-sectional study with local ethical approval only. Data sharing is not planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Zain El Den Hafez, Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randa Mahrous Roshdy, Master of Internal Medicine (+201021584548, randa011188@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary PGE-MUM Levels Discriminates Disease Activity in UC (time frame: At the time of enrollment (single visit, cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.