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RECRUITINGOBSERVATIONAL

Immunological Characteristics of Preclinical IBD

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Inclusion criteria Patients from cohort A will be included if they fulfill all the following Who May Qualify: - 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 Who May Qualify: - 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 Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Who Should NOT Join This Trial: \- Previous use of immunomodulators or biologics for any condition. Patients from cohort C will be excluded if they fulfill any the following Who Should NOT Join This Trial: - Any gastrointestinal symptoms at baseline. - Previous use of immunomodulators or biologics for any condition. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

PROCEDURE

bioespecimen samples

Blood, serum, plasma, urine, stools, small/large bowel tissue.

Locations (20)

Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi
Barcelona, Barcelona, Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Basurto
Bilbao, Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Burgos, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, Ourense, Spain
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
Vigo, Pontevedra, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Hospital Universitario Clínico de Valencia
Valencia, Valencia, Spain
Hospital Univeristario y Politécnico La Fe
Valencia, Valencia, Spain