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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
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

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital Universitario Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainNot yet recruiting
Hospital de Sant Joan Despí - Moises Broggi
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario de Basurto
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BilbaoSpainRecruiting
Hospital Universitario De Burgos
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BurgosSpainNot yet recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainNot yet recruiting
Hospital Universitario Donostia
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Donostia / San SebastianSpainNot yet recruiting
Hospital Universitario de Galdakao
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GaldakaoSpainRecruiting
Hospital Universitario de Cabueñes
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GijónSpainRecruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
Hospital Universitario de la Princesa
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MadridSpainNot yet recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
ALTHAIA, Xarxa Assistencial Universitaria de Manresa.
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ManresaSpainNot yet recruiting
Complejo Hospitalario Universitario de Ourense
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OurenseSpainNot yet recruiting
Hospital Universitario Central De Asturias
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OviedoSpainNot yet recruiting
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainNot yet recruiting
Hospital Clínico Universitario de Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitari Mútua de Terrassa
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TerrassaSpainNot yet recruiting
Hospital Universitario Clínico de Valencia
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ValenciaSpainNot yet recruiting
Hospital Univeristario y Politécnico La Fe
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ValenciaSpainNot yet recruiting
Hospital Universitario Rio Hortega
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ValladolidSpainNot yet recruiting
Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
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VigoSpainNot yet recruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.