NCT07320443

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
48mo left

Started Dec 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Dec 2025May 2030

First Submitted

Initial submission to the registry

December 4, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

December 4, 2025

Last Update Submit

December 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • This study aims to evaluate the correlation between platelet indices and disease activity in IBD

    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 Outcomes (1)

  • Correlation between platelet indices and inflammatory markers in inflammatory bowel disease

    From study enrollment up to 5 years

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

  • Hematologic malignancies or disorders.
  • Pregnancy
  • Use of antiplatelet or anticoagulant drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Sahar Atef Ahmed

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 6, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

January 6, 2026

Record last verified: 2025-12