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Clinical Trials in Spain / NCT05698745
Recruiting Observational

Immunological Characteristics of Preclinical IBD

NCT05698745 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-06-01
Last updated
2026-04-15

Condition(s) studied

Crohn DiseaseUlcerative ColitisIBD

Investigational drug(s) / intervention(s)

bioespecimen samples

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

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

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)

Trial sites (25)

FacilityCityRegionStatus
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

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Official registry record

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.

View NCT05698745 on ClinicalTrials.gov ↗ ← All trials in Spain