Immunological Characteristics of Preclinical IBD

Last updated: December 20, 2024
Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

bioespecimen samples

Clinical Study ID

NCT05698745
EARLY
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: bioespecimen samples
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
July 01, 2038

Study 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).

Connect with a study center

  • Hospital Clínico Universitario de Santiago

    Santiago De Compostela, A Coruña 15706
    Spain

    Active - Recruiting

  • Hospital Universitario de Cabueñes

    Gijón, Asturias 33394
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona 08243
    Spain

    Site Not Available

  • Hospital Universitari Mútua de Terrassa

    Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Galdakao

    Galdakao, Bizcaia 48960
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Donostia

    Donostia, Gipuzkoa 20014
    Spain

    Site Not Available

  • Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)

    Vigo, Pontevedra 36312
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    La Laguna, Santa Cruz De Tenerife 38320
    Spain

    Site Not Available

  • Hospital Universitario de Galdakao

    Galdakao, Vizcaya 48960
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital de Sant Joan Despí Moisès Broggi

    Barcelona, 08970
    Spain

    Active - Recruiting

  • Hospital Universitario de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005
    Spain

    Site Not Available

  • Hospital Univeristario y Politécnico La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario Río Hortega

    Valladolid, 47012
    Spain

    Site Not Available

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

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