Clinical trial NCT05698745: Immunological Characteristics of Preclinical IBD
Official title: Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Ulcerative Colitis
IBD
Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a new diagnosis of IBD

Brief 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).

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.

Primary outcomes:
measure: Disease progression
timeFrame: 10 years
measure: Disease progression
timeFrame: 10 years
measure: - IBD characteristics
timeFrame: 10 years
measure: Omic findings
timeFrame: 10 years
Secondary outcomes:
measure: IBD characteristics:
timeFrame: 10 years
measure: Changes in endoscopic features during follow-up
timeFrame: 10 years
measure: Microscopic characteristics at diagnosis
timeFrame: 10 years
measure: Clinical disease activity during follow-up
timeFrame: 10years
measure: Development and time to development of need for medical or surgical therapy during follow-up
timeFrame: 10years
measure: Development and time to development of extraintestinal manifestations during follow-up
timeFrame: 10years
measure: Type of extraintestinal manifestations during follow-up
timeFrame: 10years
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A Coruña
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
state: Pontevedra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Galdakao
country: Spain
facility: Hospital Universitario de Galdakao
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Valencia
country: Spain
facility: Hospital Universitario Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Univeristario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
name: Iago Rodriguez Lago, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Zabana Y, Castany G, Rodriguez E, Gutierrez A, Barreiro-de Acosta M. Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study. Therap Adv Gastroenterol. 2025 May 12;18:17562848251338647. doi: 10.1177/17562848251338647. eCollection 2025.