Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
PSC Trial Watch
Crohn'sUCRecruiting

Immunological Characteristics of Preclinical IBD

Observational · No treatment assigned · 25 sites · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Crohn Disease, Ulcerative Colitis and IBD. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Some of the main requirements, copied from the record:

Plus 11 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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).

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsCrohn Disease; Ulcerative Colitis; IBD
Lead sponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Enrollment450 (estimated)
Start date2024-06-01
Primary completion (est.)2026-07-01
First posted2023-01-26
Last updated2026-04-15
Official titleProspective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
ClinicalTrials.gov IDNCT05698745

Interventions

Full eligibility criteria (from the record)
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.

Locations (25)

SiteCityCountrySite status
Hospital General Universitario Dr. BalmisAlicanteSpainRecruiting
Hospital de Sant Joan Despí Moisès BroggiBarcelonaSpainRecruiting
Hospital Universitario de BasurtoBilbaoSpainRecruiting
Hospital Universitario de BurgosBurgosSpainNot yet recruiting
Hospital Universitario Reina SofíaCórdobaSpainNot yet recruiting
Hospital Universitario de la PrincesaMadridSpainNot yet recruiting
Hospital General Universitario Gregorio MarañónMadridSpainActive, not recruiting
Hospital Universitario Ramon y CajalMadridSpainNot yet recruiting
Hospital Universitario La PazMadridSpainNot yet recruiting
Complejo Hospitalario Universitario de OurenseOurenseSpainNot yet recruiting
Hospital Universitario Clínico de ValenciaValenciaSpainNot yet recruiting
Hospital Univeristario y Politécnico La FeValenciaSpainNot yet recruiting
Hospital Universitario Río HortegaValladolidSpainNot yet recruiting
Hospital Clínico Universitario Lozano BlesaZaragozaSpainNot yet recruiting
Hospital Universitario Miguel ServetZaragozaSpainNot yet recruiting
Hospital Clínico Universitario de SantiagoSantiago de Compostela, A CoruñaSpainRecruiting
Hospital Universitario Germans Trias i PujolBadalona, BarcelonaSpainNot yet recruiting
Althaia, Xarxa Assistencial Universitària de ManresaManresa, BarcelonaSpainNot yet recruiting
Hospital Universitari Mútua de TerrassaTerrassa, BarcelonaSpainNot yet recruiting
Hospital Universitario DonostiaDonostia / San Sebastian, GipuzkoaSpainNot yet recruiting
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)Vigo, PontevedraSpainNot yet recruiting
Hospital Universitario de CabueñesGijón, Principality of AsturiasSpainRecruiting
Hospital Universitario Central de AsturiasOviedo, Principality of AsturiasSpainNot yet recruiting
Hospital Universitario de CanariasSan Cristóbal de La Laguna, Santa Cruz De TenerifeSpainNot yet recruiting
Hospital Universitario de GaldakaoGaldakao, VizcayaSpainRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.