NCT05698745

Immunological Characteristics of Preclinical IBD

Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

Detailed description

This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses. Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).

Conditions

• Crohn Disease
• Ulcerative Colitis
• IBD

Interventions

Type	Name	Description
PROCEDURE	bioespecimen samples	Blood, serum, plasma, urine, stools, small/large bowel tissue.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-07-01
• Completion: 2038-07-01
• First posted: 2023-01-26
• Last updated: 2026-04-15

Locations

25 sites across 1 country: Spain