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

ConditionIBD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • examinations

    Procedure/Surgery

    Echo-Doppler and blood samples

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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