Ex Vivo Study of hAMSC Secretome in Inflammatory Bowel Disease: Effects on Inflammation and Fibrosis (TARGET)
NCT07721207
Digestive System Diseases, Gastroenteritis
View Trial DetailsNCT Number: NCT07320443
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 opening soon.
Get Notified18 year and older
All sexes
Observational
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
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).
Contact information is provided by the study sponsor or research team.
Assiut University
Other
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