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NCT Number: NCT07320443

Platelet Indices in Inflammatory Bowel Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sahar Atef Ahmed

CONTACT

[email protected]

01040355329

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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