Early Changes in Inflammatory Indices and Healing in IBD

September 27, 2026 updated by: Yehia Mohamed alaa aldin saad ali, Assiut University

Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease

This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.

Blood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Confirmed diagnosis of ulcerative colitis or Crohn's disease
  • Objective evidence of active disease at baseline
  • Planned initiation or escalation of IBD treatment
  • Baseline CBC with differential, CRP, and serum albumin available
  • Planned follow-up assessment at approximately 12-16 weeks
  • Planned follow-up colonoscopy with mucosal biopsies at approximately 12-16 weeks
  • Written informed consent

Exclusion Criteria:

  • Active infection
  • Recent major surgery
  • Malignancy
  • Hematological malignancy or disorder substantially altering leukocyte or platelet counts
  • Significant uncontrolled liver disease
  • Severe renal disease expected to substantially affect inflammatory markers
  • Recent blood transfusion
  • Pregnancy
  • Concomitant autoimmune inflammatory disease
  • Systemic corticosteroids used for another indication
  • Acute severe infection around the time of blood sampling
  • Inadequate follow-up or missing essential data

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Single cohort: Adult IBD Patients

Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with endoscopic healing
Time Frame: 12 to 16 weeks

Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD < 3 in Crohn's disease.
12 to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with histological healing
Time Frame: 12 to 16 weeks

Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies.
12 to 16 weeks
Mean change in neutrophil-to-lymphocyte ratio
Time Frame: Baseline and at 4 weeks

Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks.
Baseline and at 4 weeks
Mean change in C-reactive protein
Time Frame: Baseline and at 4 weeks

Mean change in C-reactive protein (CRP) level from baseline to 4 weeks.
Baseline and at 4 weeks
Mean change in CRP-to-albumin ratio
Time Frame: Baseline and at 4 weeks

Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks.
Baseline and at 4 weeks
Mean change in systemic immune-inflammation index
Time Frame: Baseline and at 4 weeks

Mean change in systemic immune-inflammation index (SII) from baseline to 4 weeks.
Baseline and at 4 weeks
Mean Mayo Endoscopic Score
Time Frame: 12 to 16 weeks

Mean Mayo Endoscopic Score in patients with ulcerative colitis (range 0-3, higher scores indicate more severe endoscopic activity).
12 to 16 weeks
Mean SES-CD score
Time Frame: 12 to 16 weeks

Mean Simple Endoscopic Score for Crohn's Disease (SES-CD) (higher scores indicate more severe endoscopic activity).
12 to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mohamed Z Hagez, prof, Internal Medicine Department, Assiut University Hospitals

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBD-Indices-Assiut-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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