NCT05698745Recruiting
Immunological Characteristics of Preclinical IBD
Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 10 Jan 2023
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05698745
What you commit to
- Study type: Observational
- Planned participants: 450
- From 1 Jun 2024 to the primary completion date, 1 Jul 2026
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Previous use of immunomodulators or biologics for any condition.
Other
- 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.
- Any gastrointestinal symptoms at baseline.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitario Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital de Sant Joan Despí - Moises Broggi Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario de Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Not yet recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Not yet recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Not yet recruiting |
| Hospital Universitario de Galdakao Coordinator of this site? Confirm its status | Galdakao | Spain | Recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| ALTHAIA, Xarxa Assistencial Universitaria de Manresa. Coordinator of this site? Confirm its status | Manresa | Spain | Not yet recruiting |
| Complejo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Not yet recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Not yet recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Not yet recruiting |
| Hospital Clínico Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitari Mútua de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Not yet recruiting |
| Hospital Universitario Clínico de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Univeristario y Politécnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Not yet recruiting |
| Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) Coordinator of this site? Confirm its status | Vigo | Spain | Not yet recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.