Role of Altered Intestinal Permeability and Lipopolysaccharide in Thrombotic Risk and Vascular Injury in IBD Patients

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06772350
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • examinations — PROCEDURE
    Echo-Doppler and blood samples

Study Details

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%.

Key Dates

Start date
Jun 15, 2025
Status verified
Dec 2024
Primary completion
Jul 15, 2026
Completion
Jun 15, 2036

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment
    Experimental

Primary Outcome Measure

Measuring altered intestinal permeability and increased thrombotic risk [ Time Frame: 1 year ]

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