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
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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).
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
- About 450 participants are expected to take part.
- Start date: 2024-06-01.
- Main results expected around 2026-07-01 (estimate from the record).
- 25 study sites listed (6 marked recruiting) in Spain.
Main thing being measured
- Disease progression (10 years)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Ulcerative Colitis; IBD |
| Lead sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Enrollment | 450 (estimated) |
| Start date | 2024-06-01 |
| Primary completion (est.) | 2026-07-01 |
| First posted | 2023-01-26 |
| Last updated | 2026-04-15 |
| Official title | Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT05698745 |
Interventions
- bioespecimen samples (Procedure)
Blood, serum, plasma, urine, stools, small/large bowel tissue.
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)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
| Hospital Clínico Universitario de Santiago | Santiago de Compostela, A Coruña | Spain | Recruiting |
| Hospital Universitario Germans Trias i Pujol | Badalona, Barcelona | Spain | Not yet recruiting |
| Althaia, Xarxa Assistencial Universitària de Manresa | Manresa, Barcelona | Spain | Not yet recruiting |
| Hospital Universitari Mútua de Terrassa | Terrassa, Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Donostia | Donostia / San Sebastian, Gipuzkoa | Spain | Not yet recruiting |
| Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) | Vigo, Pontevedra | Spain | Not yet recruiting |
| Hospital Universitario de Cabueñes | Gijón, Principality of Asturias | Spain | Recruiting |
| Hospital Universitario Central de Asturias | Oviedo, Principality of Asturias | Spain | Not yet recruiting |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna, Santa Cruz De Tenerife | Spain | Not yet recruiting |
| Hospital Universitario de Galdakao | Galdakao, Vizcaya | Spain | Recruiting |
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.