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

NCT06772350 | Not Yet Recruiting

• 1 other identifier: 7035
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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%.

Conditions

IBD

Outcome Measures

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

  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.

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Experimental

Procedure: examinations

Interventions

examinations PROCEDURE

Echo-Doppler and blood samples

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IBD (both CD and UC, both in active and quiescent stages of disease)
• Age \> 18 years
• Signature of informed consent

You may not qualify if:

• Other inflammatory states other than IBD (e.g., neoplasm, autoimmune diseases, liver cirrhosis)
• Age \< 18 years
• Pregnant woman
• Lack of informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 13, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): June 15, 2036
• Last Updated: March 13, 2025

Record last verified: 2024-12