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
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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
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
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)
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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
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...