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Evaluating early immunological characteristics of inflammatory bowel disease

Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease

Observational Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · NCT05698745

This study is trying to learn more about how inflammatory bowel disease develops in people who were recently diagnosed during cancer screening and will follow them for 10 years to see how their condition changes over time.

Quick facts

Study typeObservational
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Academic / other
Locations25 sites (Santiago de Compostela, A Coruña and 24 other locations)
Trial IDNCT05698745 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the progression of inflammatory bowel disease (IBD) by focusing on patients diagnosed during colorectal cancer screening colonoscopies. It will follow patients with new diagnoses of IBD, as well as those with recent symptomatic IBD and healthy controls, over a period of 10 years with biannual follow-ups. The study will utilize multi-omic analyses to enrich clinical information and provide insights into the natural history of IBD before symptoms develop.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a new diagnosis of IBD during a screening colonoscopy who are asymptomatic at diagnosis.

Not a fit: Patients with a long-standing history of IBD symptoms or those diagnosed with IBD more than 3 months prior to the study will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management strategies for patients with inflammatory bowel disease.

How similar studies have performed: While the approach of studying preclinical IBD is innovative, similar studies have shown promise in understanding disease progression in other chronic conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Santiago de Compostela, A Coruña and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn DiseaseUlcerative ColitisIBD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.