Evaluating early immunological characteristics of inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Clínico Universitario de Santiago
  Santiago de Compostela, A Coruña, Spain Recruiting
• Hospital Universitario de Cabueñes
  Gijón, Principality of Asturias, Spain Recruiting
• Hospital Universitario de Galdakao
  Galdakao, Vizcaya, Spain Recruiting
• 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

Study contacts

• Principal investigator: Iago Rodriguez Lago, MD — Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
• Study coordinator: Erika Araya, PhD
• Email: secretariacientifica3@geteccu.org
• Phone: +34 674682070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.