About this trial
Chronic inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), are characterized by chronic immune-mediated inflammation primarily affecting the gastrointestinal tract. Venous and arterial thromboembolic events are significant extra-intestinal manifestations of IBD, but their pathogenic mechanisms are not fully understood. IBD patients have double the risk of venous thromboembolism (VTE) compared to the general population, with particularly high risk in pediatric patients, and an increased mortality rate. They also face a higher risk of early atherosclerosis and future cardiovascular events, such as myocardial infarction, ischemic stroke, and peripheral artery disease. The prevalence of thromboembolic events in IBD ranges from 1.3% to 7.7%, with venous events at around 5% and ischemic heart disease, cerebrovascular disease, and peripheral artery disease at 1-2%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of IBD (both CD and UC, both in active and quiescent stages of disease)
Age > 18 years
Signature of informed consent
Disqualifiers
Other inflammatory states other than IBD (e.g., neoplasm, autoimmune diseases, liver cirrhosis)
Age < 18 years
Pregnant woman
Lack of informed consent
Trial design
Single group
Treatments tested in this trial
examinations
Procedure/SurgeryEcho-Doppler and blood samples
Treatment groups
Trial outcomes
Primary outcomes
Measuring altered intestinal permeability and increased thrombotic risk
altered intestinal permeability will be assessed by measurement of serum LPS and thrombotic risk by echo-Doppler examination
Secondary outcomes
Measuring the relationship between intestinal permeability and how these factors contribute to inflammation and gut microbiota changes in health and disease.
Alteration of intestinal permeability will be assessed by microbiota analysis
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: