Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05698745

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

Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2026-04-15

450

Participants Needed

25

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the natural history and immunological and genetic characteristics of preclinical Inflammatory Bowel Disease (IBD), including Crohn Disease and Ulcerative Colitis. This observational study focuses on the earliest stages of IBD, before symptoms appear, to understand disease progression and complications such as fistulas, abscesses, and strictures. The study is a collaborative, multicenter research project aimed at gaining new insights into IBD development through long-term follow-up and advanced analyses. Participants include three groups: asymptomatic patients newly diagnosed with IBD during colorectal cancer screening colonoscopies, patients with new-onset symptomatic IBD diagnosed within the last 3 months, and healthy controls with normal colonoscopies and no signs of IBD. The study follows participants for 10 years, with visits every 6 months. During this time, blood, serum, plasma, urine, stool, and bowel tissue samples will be collected for multi-omic analyses, alongside clinical assessments. Throughout the 10-year period, participants will have detailed evaluations including clinical visits, colonoscopy findings, and monitoring of disease characteristics, activity, and complications. Researchers will track the development of symptoms, need for medical or surgical treatment, and extraintestinal manifestations. The study aims to provide a comprehensive understanding of IBD progression using both clinical data and biological samples collected over time.

CONDITIONS

Brief Title

Immunological Characteristics of Preclinical IBD

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older at baseline
  • New diagnosis of IBD during colorectal cancer screening colonoscopy using European Crohn's and Colitis Organization criteria
  • Presence of chronic inflammatory infiltrate and histological diagnosis compatible with IBD for cohort A
  • Asymptomatic at diagnosis with no previous IBD symptoms for cohort A
  • Time between index colonoscopy and baseline visit up to 3 months
  • Recent diagnosis of symptomatic IBD with less than 3 months from symptom onset for cohort B
  • No endoscopic signs of IBD after complete ileo-colonoscopy for healthy controls (cohort C)
  • Male or female aged 18 years or older for all cohorts
Not Eligible

You will not qualify if you...

  • Identification of enteropathogen in stool culture for cohort A
  • Only acute inflammatory infiltrate without signs of chronicity for cohort A
  • Previous or current microscopic colitis for cohort A
  • Previous use of immunomodulators or biologics for any condition for cohorts B and C
  • Any gastrointestinal symptoms at baseline for healthy controls (cohort C)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo colorectal cancer screening colonoscopies to identify new diagnoses of inflammatory bowel disease or confirm absence of disease.

1 visit (in-person)

Long-term Monitoring

Duration - 10 years

Participants are followed with clinical visits every 6 months for up to 10 years to monitor disease progression, clinical activity, and collect biological samples for multi-omic analyses.

Visits every 6 months for 10 years

Trial Site Locations

Total: 25 locations

1

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

2

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Not Yet Recruiting

3

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain, 08243

Not Yet Recruiting

4

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Spain, 08221

Not Yet Recruiting

5

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, Spain, 20014

Not Yet Recruiting

6

Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)

Vigo, Pontevedra, Spain, 36312

Not Yet Recruiting

7

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, Spain, 33394

Actively Recruiting

8

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain, 33011

Not Yet Recruiting

9

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320

Not Yet Recruiting

10

Hospital Universitario de Galdakao

Galdakao, Vizcaya, Spain, 48960

Actively Recruiting

11

Hospital General Universitario Dr. Balmis

Alicante, Spain, 03010

Actively Recruiting

12

Hospital de Sant Joan Despí Moisès Broggi

Barcelona, Spain, 08970

Actively Recruiting

13

Hospital Universitario de Basurto

Bilbao, Spain, 48013

Actively Recruiting

14

Hospital Universitario de Burgos

Burgos, Spain, 09006

Not Yet Recruiting

15

Hospital Universitario Reina Sofía

Córdoba, Spain, 14004

Not Yet Recruiting

16

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Not Yet Recruiting

17

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Active, Not Recruiting

18

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Not Yet Recruiting

19

Hospital Universitario La Paz

Madrid, Spain, 28046

Not Yet Recruiting

20

Complejo Hospitalario Universitario de Ourense

Ourense, Spain, 32005

Not Yet Recruiting

21

Hospital Universitario Clínico de Valencia

Valencia, Spain, 46010

Not Yet Recruiting

22

Hospital Univeristario y Politécnico La Fe

Valencia, Spain, 46026

Not Yet Recruiting

23

Hospital Universitario Río Hortega

Valladolid, Spain, 47012

Not Yet Recruiting

24

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Not Yet Recruiting

25

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Not Yet Recruiting

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Research Team

E

Erika Araya, PhD

I

Iago Rodriguez Lago, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study.

Iago Rodríguez-Lago, Urko M Marigorta, Beatriz Mateos...

https://pubmed.ncbi.nlm.nih.gov/40365077