Immunological Characteristics of Preclinical IBD

Official title

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

Overview

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).

Interventions

• Procedure bioespecimen samples
  Blood, serum, plasma, urine, stools, small/large bowel tissue.

Primary outcome measures

• Disease progression [Time frame: 10 years]
• Disease progression [Time frame: 10 years]
• - IBD characteristics [Time frame: 10 years]
• Omic findings [Time frame: 10 years]

Secondary outcome measures (7)

• IBD characteristics: [Time frame: 10 years]
• Changes in endoscopic features during follow-up [Time frame: 10 years]
• Microscopic characteristics at diagnosis [Time frame: 10 years]
• Clinical disease activity during follow-up [Time frame: 10years]
• Development and time to development of need for medical or surgical therapy during follow-up [Time frame: 10years]
• Development and time to development of extraintestinal manifestations during follow-up [Time frame: 10years]
• Type of extraintestinal manifestations during follow-up [Time frame: 10years]

Eligibility criteria

Inclusion criteria

Patients from cohort A will be included if they fulfill all the following inclusion criteria:

• Male or female ≥18 years of age at baseline.
• New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).
• Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.
• The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.
• Time interval between the index colonoscopy and the baseline visit up to 3 months.

Patients from cohort B will be included if they fulfill all the following inclusion criteria:

• Male or female ≥18 years of age at baseline.
• Recent diagnosis of IBD, with <3 months from symptoms onset.
• Time interval between the index colonoscopy and the baseline visit up to 3 months.

Patients from cohort C will be included if they fulfill all the following inclusion criteria:

• Male or female ≥18 years of age at baseline.
• No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.
• Time interval between the index colonoscopy and the baseline visit up to 3 months.

Exclusion criteria

Patients from cohort A will be excluded if they fulfill any the following exclusion criteria:

• Identification of any enteropathogen in the stool culture.
• Isolated findings of acute inflammatory infiltrate without signs of chronicity.
• Previous or current diagnosis of microscopic colitis.
• Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.

Patients from cohort B will be excluded if they fulfill any the following exclusion criteria:

\- Previous use of immunomodulators or biologics for any condition.

Patients from cohort C will be excluded if they fulfill any the following exclusion criteria:

• Any gastrointestinal symptoms at baseline.
• Previous use of immunomodulators or biologics for any condition.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Spain · 25 centers

• Hospital Clínico Universitario de Santiago — Santiago de Compostela
• Hospital Universitario Germans Trias i Pujol — Badalona
• Althaia, Xarxa Assistencial Universitària de Manresa — Manresa
• Hospital Universitari Mútua de Terrassa — Terrassa
• Hospital Universitario Donostia — Donostia / San Sebastian
• Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) — Vigo
• Hospital Universitario de Cabueñes — Gijón
• Hospital Universitario Central de Asturias — Oviedo
• … and 17 more centers

Publications

• Rodriguez-Lago I, Marigorta UM, Mateos B, Manosa M, Marquez-Mosquera L, Menchen L, Rodriguez-Moranta F, Alonso I, Aguas M, Alonso-Galan H, Borras P, Castro B, Domenech E, Ferreiro-Iglesias R, de Francisco R, Garcia-Alonso FJ, Garcia N, Garcia-Bosch O, Gargallo C, Gisbert JP, Iglesias E, Mesonero F, Ortiz de Zarate J, Ramos L, Sainz E, Ladron P, Suria C, Ferrer CS, Tejido C, Varela P, Vicente R, Za PMID 40365077

Identifiers

NCT: NCT05698745 · EARLY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗