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Machine Learning Approach to Study the Interactions Between Environment and Intestinal Tissue Homeostasis in IBD

NCT06120322 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-11-07

No results posted yet for this study

Summary

The intestinal epithelial barrier is one of the most important security checkpoints of our body that constrains harmful factors from invading mucosal surfaces and facilitates the absorption of nutrients and water. Its correct functioning is essential for maintaining gut tissue homeostasis and proper immunity. However, such an equilibrium may be interrupted, resulting in an uncontrolled entrance of pathogenic stimuli that in turn activate a persistent gut immune response, with detrimental consequences for both local and systemic immunity. Alterations in the composition and functionality of the gut microbiome seem to be a central factor in affecting gut barrier integrity thus influencing intestinal permeability. The microbiome composition is impacted by dietary habits and environmental pollution and conditions, hygiene, genetic asset, and physical activity, which could interact in concert leading to dysbiosis, thereby influencing the immune response through the production of several metabolites. Chronic inflammatory diseases, including ulcerative colitis (UC) and type 1 diabetes (T1D), share microbiota dysbiosis, among pathologic characteristics, that may arise, be provoked, or be exacerbated because of barrier leakage. Therefore, these two chronic diseases may be considered prototype pathologies where the intrinsic connection between intestinal dysbiosis and the barrier leakage impact each other during the pathogenesis.

Conditions

Interventions

OTHER

Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies

During the routine surveillance according to the normal clinical practice, blood samples, feces and urines will be collected from UC patients and T1D patients (0, 6, and 12 months). Moreover, for UC patients during the surveillance sigmoidoscopy according to the normal clinical practice (or colonoscopy if the patient has more than 8 years; at the enrollment and after 12 months), colonic biopsies will be collected

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-05-01
Completion
2025-11-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120322 on ClinicalTrials.gov