Ulcerative ColitisNCT07261579
Composite Ratios Boost CRP's Power in Monitoring Ulcerative Colitis.
An observational study of Ulcerative Colitis, run by Benha University at 1 site in Egypt.
Trial summary
Inflammatory Bowel Disease (IBD) is a chronic, recurrent condition marked by disturbed levels of various hematological inflammatory cells and a deregulated immune environment. While C-reactive protein (CRP) is a key acute-phase reactant, its high levels can persist even after inflammation subsides. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- C-Reactive Protein measuring CRP and CRP to Albumin Ratio
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consisted of all patients exhibiting clinical signs suggestive of Inflammatory Bowel Disease were assessed for Ulcerative Colitis diagnostic criteria.
Who may be able to join
- Patients who fulfilled the diagnostic criteria for UC;
- Patients were free of exclusion criteria;
- Patients who signed the written consent were enrolled in the study
Who cannot join
- Patients who was Previously diagnosed with IBD or IBS;
- Patients with recurrence of manifestations after surgical resection;
- Patients who refused to sign the participation consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Composite Inflammatory Parameters Ratios Enforce the Role of CRP for Monitoring Ulcerative Colitis Disease Activity
Inflammatory Bowel Disease (IBD) is a chronic, recurrent condition marked by disturbed levels of various hematological inflammatory cells and a deregulated immune environment. While C-reactive protein (CRP) is a key acute-phase reactant, its high levels can persist even after inflammation subsides. Other simple, cost-effective ratios, such as the Neutrophil-to-Lymphocyte Ratio (NLR), the Platelet-to-Lymphocyte Ratio (PLR), and Albumin-related ratios, also serve as promising, reproducible markers of systemic inflammation reflecting both immune status and nutrition. This study's objective is to evaluate the diagnostic performance of these various hematological inflammatory cellular components and CRP-related ratios (like the CAR) as predictors for Ulcerative Colitis (UC) disease severity, using colonoscopic and microscopic findings as the gold standard for comparison.
- Conditions
- Ulcerative Colitis
- Being tested
- C-Reactive Protein measuring CRP, CRP to Albumin Ratio
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Reactive Protein measuring CRPDiagnostic test
5-ml peripheral blood samples were aseptically obtained for a complete blood count, and ELISA estimation of serum CRP
CRP to Albumin RatioDiagnostic test
Serum CRP to albumin ratio (CAR) is a combination of markers for systemic inflammation and nutritional status
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis Patients | Patients exhibiting clinical signs suggestive of IBD were assessed for UC diagnostic criteria, and the study inclusion and exclusion standards. Receives: Diagnostic Test: C-Reactive Protein measuring CRP; Diagnostic Test: CRP to Albumin Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Correlation Between Clinical and Endoscopic Diagnostic Indices and Hematologic Ratios
Evaluating the role of diagnostic indices (Ulcerative Colitis Disease Activity Index (UC-DAI), Simple Clinical Colitis Activity Index (SCCAI), Fecal Calprotectin (FCP) ≥150μg/ml) in active Ulcerative Colitis (UC) and their correlation with novel hematologic inflammatory markers, including Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Inflammatory Response Index (SIRI), Systemic Inflammation Index (SII), and the serum C-Reactive Protein (CRP)-to-Albumin Ratio (CAR).
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Sep 2025
- Primary completion25 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raafat R. Mohammed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261579
- Sponsor's protocol ID
- E/C. S/N. R14/2025
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Inflammatory Parameters Ratios Enforce the Role of CRP for Monitoring Ulcerative Colitis Disease Activity
- ClinicalTrials.gov ID
- NCT07261579
- Acronym / sponsor ID
- E/C. S/N. R14/2025
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 3 Dec 2025 (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.
Inflammatory Bowel Disease (IBD) is a chronic, recurrent condition marked by disturbed levels of various hematological inflammatory cells and a deregulated immune environment. While C-reactive protein (CRP) is a key acute-phase reactant, its high levels can persist even after inflammation subsides. Other simple, cost-effective ratios, such as the Neutrophil-to-Lymphocyte Ratio (NLR), the Platelet-to-Lymphocyte Ratio (PLR), and Albumin-related ratios, also serve as promising, reproducible markers of systemic inflammation reflecting both immune status and nutrition. This study's objective is to evaluate the diagnostic performance of these various hematological inflammatory cellular components and CRP-related ratios (like the CAR) as predictors for Ulcerative Colitis (UC) disease severity, using colonoscopic and microscopic findings as the gold standard for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis Patients | – | Diagnostic Test: C-Reactive Protein measuring CRP, Diagnostic Test: CRP to Albumin RatioPatients exhibiting clinical signs suggestive of IBD were assessed for UC diagnostic criteria, and the study inclusion and exclusion standards. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of all patients exhibiting clinical signs suggestive of Inflammatory Bowel Disease were assessed for Ulcerative Colitis diagnostic criteria.
Key inclusion criteria (3 listed)
- Patients who fulfilled the diagnostic criteria for UC;
- Patients were free of exclusion criteria;
- Patients who signed the written consent were enrolled in the study
Key exclusion criteria (3 listed)
- Patients who was Previously diagnosed with IBD or IBS;
- Patients with recurrence of manifestations after surgical resection;
- Patients who refused to sign the participation consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Reactive Protein measuring CRP5-ml peripheral blood samples were aseptically obtained for a complete blood count, and ELISA estimation of serum CRP | Diagnostic test | Ulcerative Colitis Patients |
| CRP to Albumin RatioSerum CRP to albumin ratio (CAR) is a combination of markers for systemic inflammation and nutritional status | Diagnostic test | Ulcerative Colitis Patients |
Primary outcome
The Correlation Between Clinical and Endoscopic Diagnostic Indices and Hematologic Ratios
Time frame: 45 days
Evaluating the role of diagnostic indices (Ulcerative Colitis Disease Activity Index (UC-DAI), Simple Clinical Colitis Activity Index (SCCAI), Fecal Calprotectin (FCP) ≥150μg/ml) in active Ulcerative Colitis (UC) and their correlation with novel hematologic inflammatory markers, including Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Inflammatory Response Index (SIRI), Systemic Inflammation Index (SII), and the serum C-Reactive Protein (CRP)-to-Albumin Ratio (CAR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Benha 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Correlation Between Clinical and Endoscopic Diagnostic Indices and Hematologic Ratios (time frame: 45 days). 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 21 Jan 2026.