- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07261579
Composite Ratios Boost CRP's Power in Monitoring Ulcerative Colitis.
January 19, 2026 updated by: Raafat R. Mohammed, Benha University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El Alexandria
-
Alexandria, El Alexandria, Egypt, 21512
- Alexandria Faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consisted of all patients exhibiting clinical signs suggestive of Inflammatory Bowel Disease were assessed for Ulcerative Colitis diagnostic criteria.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ulcerative Colitis Patients
Patients exhibiting clinical signs suggestive of IBD were assessed for UC diagnostic criteria, and the study inclusion and exclusion standards.
|
5-ml peripheral blood samples were aseptically obtained for a complete blood count, and ELISA estimation of serum CRP
Serum CRP to albumin ratio (CAR) is a combination of markers for systemic inflammation and nutritional status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
45 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2025
Primary Completion (Actual)
November 25, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
November 22, 2025
First Submitted That Met QC Criteria
November 22, 2025
First Posted (Actual)
December 3, 2025
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E/C. S/N. R14/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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