Platelet Indices in Inflammatory Bowel Diseases

December 25, 2025 updated by: Sahar Atef Ahmed Ali, Assiut University

Inflammatory bowel disease (IBD) is a chronic, immune-mediated condition characterized by relapsing inflammation of the gastrointestinal tract. It primarily includes two subtypes: ulcerative colitis (UC) and Crohn's disease (CD), both of which have shown a rising incidence globally over recent decades .The pathogenesis of IBD is complex and multifactorial, involving a dynamic interplay of genetic susceptibility, immune dysregulation, environmental exposures, and gut microbiota alterations .

Recent studies have highlighted the emerging role of platelets beyond hemostasis, particularly in immune modulation and inflammation . Patients with IBD exhibit several platelet-related abnormalities, including changes in platelet count, size, shape, and activation status . These alterations may result from the chronic systemic inflammation characterizing IBD, leading to enhanced platelet reactivity and a prothrombotic state .

Evidence suggests that inflammatory cytokines can trigger coagulation pathways, which in turn amplify inflammation, forming a self-perpetuating cycle . This interplay between inflammation and thrombosis has clinical implications, as IBD patients are at increased risk for thromboembolic events . Mean platelet volume (MPV), plateletcrit (PCT), platelet distribution width (PDW), and platelet count (PLT) are readily accessible indices from a complete blood count that may reflect platelet activity and inflammatory status .

Despite these associations, results from previous studies on platelet indices in IBD patients remain inconsistent. A recent systematic review and meta-analysis demonstrated that MPV is significantly lower in IBD patients compared to healthy controls, while PLT and PCT tend to be elevated .However, the diagnostic and prognostic utility of these indices in clinical practice remains undefined.

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

we aim to investigate the relationship between platelet indices (MPV, PDW, PCT, PLT) and disease activity in patients with inflammatory bowel disease. We also aim to evaluate the potential correlation between these platelet parameters and established inflammatory markers such as CRP, ESR, and fecal calprotectin. This may help clarify whether platelet indices can serve as accessible, cost-effective biomarkers in the clinical assessment of IBD

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.
84

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

: Assiut University hospitals IBD out patient clinic and internal medicine department

Description

Inclusion Criteria:

  • a. Inclusion criteria:

    • Adult patients (age >18) with confirmed diagnosis of UC , Crohn's b. Exclusion criteria:
  • Hematologic malignancies or disorders.
  • Pregnancy
  • Use of antiplatelet or anticoagulant drugs

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

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
This study aims to evaluate the correlation between platelet indices and disease activity in IBD
Time Frame: From study enrollment up to 5 years.

Correlation between platelet indices and disease activity in inflammatory bowel disease This study aims to assess the correlation between platelet indices and disease activity in patients with inflammatory bowel disease.

Platelet indices, including mean platelet volume (MPV), platelet distribution width (PDW), plateletcrit (PCT), and platelet count (PLT), will be measured as continuous variables obtained from complete blood count analysis. Disease activity will be assessed using validated clinical disease activity indices: the Partial Mayo Score for ulcerative colitis and the Crohn's Disease Activity Index (CDAI) for Crohn's disease.

The correlation between platelet indices and disease activity scores will be evaluated using correlation coefficients (Pearson or Spearman)
From study enrollment up to 5 years.

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
Correlation between platelet indices and inflammatory markers in inflammatory bowel disease
Time Frame: From study enrollment up to 5 years

This study aims to assess the correlation between platelet indices and inflammatory markers in patients with inflammatory bowel disease.

Platelet indices (MPV, PDW, PCT, and PLT) will be correlated with inflammatory markers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), using correlation coefficients (Pearson or Spearman).
From study enrollment up to 5 years

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

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.
December 30, 2025

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.
May 1, 2030

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.
May 1, 2030

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).
December 4, 2025

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.
December 25, 2025

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.
January 6, 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.
January 6, 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.
December 25, 2025

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.
December 1, 2025

More Information

Terms related to this study

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.
  • platelet indices in IBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Study Protocol

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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