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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)
Disease progression — 10 years Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).
Disease progression — 10 years Time to development of symptomatic disease during follow-up.
- IBD characteristics — 10 years * Type (CD or UC)
* Disease extent (CD or UC) according to Montreal classification
* CD phenotype at diagnosis (Montreal classification)
* Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent
* Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up
Omic findings — 10 years proteomic, transcriptomic, serologic, microbiota, and tissue data
Trial sites (25)
Facility
City
Region
Status
Hospital Clínico Universitario de Santiago
Santiago de Compostela
A Coruña
Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona
Barcelona
Not Yet Recruiting
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa
Barcelona
Not Yet Recruiting
Hospital Universitari Mútua de Terrassa
Terrassa
Barcelona
Not Yet Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian
Gipuzkoa
Not Yet Recruiting
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
Vigo
Pontevedra
Not Yet Recruiting
Hospital Universitario de Cabueñes
Gijón
Principality of Asturias
Recruiting
Hospital Universitario Central de Asturias
Oviedo
Principality of Asturias
Not Yet Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Santa Cruz De Tenerife
Not Yet Recruiting
Hospital Universitario de Galdakao
Galdakao
Vizcaya
Recruiting
Hospital General Universitario Dr. Balmis
Alicante
Spain
Recruiting
Hospital de Sant Joan Despí Moisès Broggi
Barcelona
Spain
Recruiting
Hospital Universitario de Basurto
Bilbao
Spain
Recruiting
Hospital Universitario de Burgos
Burgos
Spain
Not Yet Recruiting
Hospital Universitario Reina Sofía
Córdoba
Spain
Not Yet Recruiting
Hospital Universitario de la Princesa
Madrid
Spain
Not Yet Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Spain
Active Not Recruiting
Hospital Universitario Ramon y Cajal
Madrid
Spain
Not Yet Recruiting
Hospital Universitario La Paz
Madrid
Spain
Not Yet Recruiting
Complejo Hospitalario Universitario de Ourense
Ourense
Spain
Not Yet Recruiting
Hospital Universitario Clínico de Valencia
Valencia
Spain
Not Yet Recruiting
Hospital Univeristario y Politécnico La Fe
Valencia
Spain
Not Yet Recruiting
Hospital Universitario Río Hortega
Valladolid
Spain
Not Yet Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Spain
Not Yet Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Spain
Not Yet Recruiting
More Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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